Background

Health Canada’s Cannabis Legalization and Regulation Branch was the authority responsible for licensing and compliance monitoring under the Access to Cannabis for Medical Purposes Regulations (ACMPR). The Cannabis Directorate of Health Canada’s Regulatory Operations and Enforcement Branch (formerly Regulatory Operations and Regions Branch) delivers on a compliance and enforcement mandate that supports the Controlled Substances and Cannabis Branch (formerly Cannabis Legalization and Regulation Branch) and conducts inspections and compliance verifications to enforce the Regulations. Compliance and enforcement activities help to protect the health and safety of Canadians and reduce the risk of diversion by identifying deficiencies and implementing corrective measures. Health Canada uses a risk-based approach to monitor licensed producers to ensure they meet the good production practices, security directives and other requirements of the ACMPR, the Controlled Drugs and Substances Act (CDSA) and the Food and Drugs Act (FDA).

Fiscal year 2017-2018 Changes to inspection types In May 2017, Health Canada introduced several improvements to streamline the application process for production licences and enable increased production under Part 1 of the ACMPR. More information on improvements can be found in the statement and backgrounder that was issued at that time. Following the announcement, Health Canada began scheduling the first inspection of a facility after it determined that an application met all regulatory requirements and after the Department had issued a licence to cultivate. Previously, applicant facilities were inspected prior to Health Canada issuing a cultivation licence. As a result of this change, Health Canada updated its inspection terminology to reflect the new approach. Please refer to the table below for more detail on the changes made to the Inspection types, which were fully implemented by July 2017. Former Inspection types New Inspection types Pre-licence inspection Conducted to assess whether the information submitted to Health Canada in a licence application or amendment is accurate. Introductory inspection Conducted to verify that the licensed producer is meeting the requirements of the ACMPR including, but not limited to, the physical security requirements for the site, record-keeping practices and Good Production Practices (GPP) and to confirm that the activities being conducted by the licensed producer correspond to those indicated on their licence. Initial inspection Conducted when cannabis is ready for sale and testing is completed to assess whether the facilities, activities, and products are in compliance with the Good Production Practices and record keeping requirements. Pre-sales inspection Conducted prior to the issuance of a sales licence to verify that the licensed producer is meeting the requirements of the ACMPR including, but not limited to, GPP, packaging, labelling, shipping, and record keeping. Targeted inspection Conducted to verify compliance with particular areas of the ACMPR. Targeted inspection Conducted to verify compliance with particular areas of the ACMPR. Regular inspection Conducted to monitor and verify compliance with the requirements ACMPR, CDSA, and FDA prior to licence renewal. Annual inspection Conducted to monitor and verify compliance with the requirements of the ACMPR, CDSA, and FDA. Observations An observation is a deficiency or deviation from legislative or regulatory requirements noted by an inspector during an inspection and is classified as minor, major, or critical. Pre-licence and Initial inspections (April – June 2017) and Pre-sale inspections (June 2017 – March 2018) assessed the applicant’s or the licensed producer’s readiness to conduct various activities outlined within an application. Therefore, observations were not rated during these inspections. Minor

Minor observations will likely not increase the risk of diversion, prevent the detection of diversion, and/or health risk.

Minor observations will likely not increase the risk of diversion, prevent the detection of diversion, and/or health risk. Major

Major observations may increase the risk of diversion, prevent the detection of diversion, and/or health risk.

Major observations may increase the risk of diversion, prevent the detection of diversion, and/or health risk. Critical

Critical observations will likely increase the immediate risk of diversion, prevent the detection of diversion, and/or present an imminent health risk, and may also involve the possibility of deliberate fraud, misinterpretation, or falsification of information. Inspection rating An inspection can be assigned a compliant or non-compliant rating based on the number and severity of observations noted during an inspection. It should be noted that a compliant inspection rating may be assigned when observations are present. Pre-licence, Initial and Pre-sales inspections were not assigned inspection ratings since observations are not rated. Compliant

A compliant inspection rating means that at the time of the inspection, the licensed producer has met the applicable legislative and regulatory requirements, and is in control of the regulated activities.

A compliant inspection rating means that at the time of the inspection, the licensed producer has met the applicable legislative and regulatory requirements, and is in control of the regulated activities. Non-Compliant

A non-compliant inspection rating means that at the time of the inspection, the licensed producer has not met the applicable legislative and regulatory requirements, and is not in control of the regulated activities. Significant compliance actions A significant compliance action may be taken to correct instances of non-compliance. These may include, but are not limited to, issuance of warning letters, seizure and detention of products, licence suspension or revocations. It is important to note that a licensed producer may have had a significant compliance action with a compliant Inspection rating. This is possible due to the corrective measures taken to address the non-compliance and prevent any future non-compliance. Inspection data: Part 1 inspections The following table presents inspection data by the month in which they were conducted. All inspections from April 1, 2017 to March 31, 2018 were conducted under the ACMPR. Inspection data summary March 2018 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Acreage Pharms Ltd. Pre-sales N/A N/A N/A Agri-Medic ASP Inc. Introductory Minor Compliant None Aurora Cannabis Enterprises Inc. (3rd site) Introductory Minor

Major Compliant None Canada's Island Garden Inc. Annual Minor

Major Compliant None CanniMed Ltd. Pre-sales N/A N/A N/A CannTrust Inc. Pre-sales N/A N/A N/A DelShen Therapeutics Corp. Pre-sales N/A N/A N/A FV Pharma Inc. Introductory Minor Compliant None James E. Wagner Cultivation Ltd. Targeted Minor Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Pre-sales N/A N/A N/A Sundial Growers Inc. Pre-sales N/A N/A N/A Tantalus Labs Ltd. Annual Minor Compliant None Highland Grow Inc. [previously THC Dispensaries Canada Inc.] Introductory Minor

Major Compliant None Thrive Cannabis Pre-licence N/A N/A N/A Tweed Inc. Targeted Minor

Major Compliant None United Greeneries Ltd. Annual Minor

Major Compliant None Vert Cannabis Inc. Introductory Minor Compliant None WILL Cannabis Corp. Introductory Minor Compliant None Zenabis Ltd. Pre-sales N/A N/A N/A Zenabis Ltd. (2nd site) Pre-sales N/A N/A N/A Inspection data summary February 2018 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Agrima Botanicals Corp. Introductory Minor Compliant None Beleave Kannabis Corp. [previously First Access Medical Inc.] Pre-sales N/A Compliant None Beleave Kannabis Corp. [previously First Access Medical Inc.] Annual Minor Compliant None Breathing Green Solutions Inc. Introductory Minor Compliant None Broken Coast Cannabis Ltd. Annual Minor Compliant None Canna Farms Ltd. Pre-sales N/A N/A N/A Delta 9 Bio-Tech Inc. Targeted Minor

Major Compliant None DOJA Cannabis Ltd. Pre-sales N/A N/A N/A Green Relief Inc. Pre-sales N/A N/A N/A Hydropothecary Targeted Minor Compliant None James E. Wagner Cultivation Ltd. Pre-sales N/A N/A N/A Medical Marihuana Group Corporation Introductory Minor Compliant None Original BC Ltd. Targeted Minor Compliant None Peace Naturals Project Inc. Targeted Minor Compliant None Quality Green Inc. Introductory Minor

Major Compliant None RedeCan Pharm (2nd site) Targeted Minor Compliant None Spectrum Cannabis Canada Ltd. [previously Mettrum Ltd.] Targeted Minor Compliant None The Flowr Group (Okanagan) Inc. Introductory Minor Compliant None Tilray Pre-sales N/A N/A N/A Tweed Farms Targeted Minor Compliant None Tweed Inc. Targeted Minor Compliant None Zenabis Ltd. (2nd site) Targeted Minor Compliant None Inspection Data Summary January 2018 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions 7 Acres Annual Minor

Major Compliant None A B Laboratories Targeted Minor

Major Compliant None Aurora Cannabis Enterprises Inc. Targeted Minor Compliant None Aurora Cannabis Enterprises Inc. (2nd site) Introductory Minor Compliant None Bonify Medical Cannabis Annual Minor Compliant None CannTrust Inc. (2nd site) Targeted Minor Compliant None CannTrust Inc. (2nd site) Pre-sales N/A N/A N/A Experion Biotechnologies Inc. Introductory Minor

Major Compliant None Alberta Craft Cannabis [previously GrenEx Pharms Inc. Introductory Minor Compliant None HydRx Farms Ltd. Introductory Minor Compliant None Indiva Inc. Targeted Minor Compliant None James E. Wagner Cultivation Ltd. Targeted Minor Compliant None Maricann Inc. (2nd site) Introductory Minor Compliant None Maricann Inc. Annual Minor

Major Compliant None MedReleaf Corp. Pre-sales N/A N/A N/A MedReleaf Corp. (2nd site) Annual Minor Compliant None Potanicals Green Growers Inc. Introductory Minor Compliant None Kolab Project Inc. [previously RockGarden Medicinals (2014) Inc.] Targeted Minor Compliant None Solace Health Inc. Targeted Minor Compliant None Solace Health Inc. Pre-sales N/A N/A N/A Sundial Growers Inc. Targeted Minor Compliant None THC BioMed Ltd. Annual Minor Compliant None WeedMD Rx Inc. Annual Minor Compliant None Inspection Data Summary December 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Acreage Pharms Ltd. Annual Minor

Major Compliant None Agrima Botanicals Corp. Targeted Minor Compliant None Aphria Targeted – random testingFootnote 4 N/A N/A None Bedrocan Canada Inc. Targeted Minor Compliant None Bedrocan Canada Inc. (2nd site) Annual Minor

Major Compliant None Beleave Kannabis Corp. [previously First Access Medical Inc.] Targeted Major Compliant None Emerald Health Therapeutics Canada Inc. Targeted Minor

Major Compliant None Evergreen Medicinal Supply Inc. Annual Minor

Major Compliant None MedReleaf Corp. Targeted – random testingFootnote 4 N/A N/A None MedReleaf Corp. Annual Minor

Major Compliant None Natura Naturals Inc. Introductory Minor

Major Compliant None Natural Med Company Targeted – random testingFootnote 4 N/A N/A N/A Natural Med Company Targeted – witness destruction N/A N/A N/A Natural Med Company Targeted Major Compliant None Northern Lights Marijuana Company Ltd. Targeted Minor Compliant None OrganiGram Inc. Annual Minor

Major Compliant None The Green Organic Dutchman Ltd. Targeted Minor Compliant None United Greeneries Ltd. Targeted Minor Compliant None UP Cannabis Inc. Targeted Minor Compliant None Whistler Medical Marijuana Corp. Targeted – random testingFootnote 4 N/A N/A None Whistler Medical Marijuana Corp. Targeted Yes No No Inspection Data Summary November 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions A B Laboratories Pre-sales N/A Compliant None ABcann

Medicinals Inc. Targeted and random testingFootnote 4 Minor Compliant None ABcann

Medicinals Inc. Targeted – random testingFootnote 4 N/A Compliant None Agrima Botanicals Corp. Targeted Critical Non-compliant1 Warning letter issued due to activities taking place at the site that were not authorized by the licence. Compliance with the regulations achieved following the warning letterFootnote 2 Agripharm Corp. Annual Minor Compliant None Canada's Island Garden Inc. Targeted and random testingFootnote 4 Minor Compliant None Canna Farms Ltd. Annual Minor Compliant None Canna Farms Ltd. Targeted – random testingFootnote 4 N/A N/A None CannTrust Inc. Annual Minor

Major Compliant Warning letter issued as the production process for cannabis oil was changed without submitting a licence amendment applicationFootnote 2 CannTrust Inc. Targeted – random testingFootnote 4 N/A N/A None CannTrust Inc.

(2nd site) Introductory Minor Compliant None DelShen Therapeutics Corp. Annual Minor

Major Compliant None Delta 9 Bio-Tech Inc. Targeted – random testingFootnote 4 N/A N/A None Delta 9 Bio-Tech Inc. Targeted Minor N/A N/A Emblem Cannabis Corp. Targeted No Compliant None Experion Biotechnologies Inc. Targeted Minor Compliant None Green Relief Inc. Annual Minor

Major Compliant None Green Relief Inc. Targeted – random testingFootnote 4 N/A Compliant None International Herbs Medical Marijuana Ltd. (2nd site) Introductory Minor Compliant None International Herbs Medical Marijuana Ltd. Targeted Minor Compliant None Peace Naturals Project Inc. Targeted Minor

Major Compliant None Prairie Plant Systems Inc. Annual Minor

Major Compliant None Prairie Plant Systems Inc. Targeted – random testingFootnote 4 N/A Compliant None RedeCan Pharm (2nd site) Introductory Minor Compliant None RedeCan Pharm Targeted No N/A None Tantalus Labs Ltd. Targeted Minor Compliant None Tweed Grasslands Cannabis Inc., [previously rTrees Producers Limited] Pre-sales N/A Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Targeted Minor Compliant None Spectrum Cannabis Canada Ltd. [previously Mettrum Ltd.] Targeted Minor Compliant None We Grow BC Ltd. Introductory Minor

Major Compliant None Whistler Medical Marijuana Corp. Pre-sales N/A N/A None Inspection Data Summary October 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions A B Laboratories Targeted Minor Compliant None Aphria Targeted Minor Compliant None Aphria Targeted – random testingFootnote 4 N/A N/A None Bonify Medical Cannabis Targeted Minor Compliant None Broken Coast Cannabis Ltd. Targeted Minor Compliant None Canveda Inc. Targeted No Compliant None Evergreen Medicinal Supply Inc. Targeted Minor

Major Compliant None Hydropothecary Targeted No Compliant None Indiva Inc. Introductory Minor

Major Compliant None James E. Wagner Cultivation Ltd. Annual Minor

Major Compliant None KoLab Project Inc. [previously RockGarden Medicinals Inc.] Introductory Minor Compliant None MedReleaf Corp. (2nd site) Targeted No Compliant None MedReleaf Corp. (2nd site) Pre-sales N/A N/A N/A Original BC Ltd. [previously In The Zone Produce Ltd.] Annual Minor

Major Compliant None Solace Health Inc. Introductory Minor

Major Compliant None Sundial Growers Inc. Targeted Minor

Major Compliant None THC BioMed Ltd. Targeted Minor

Major Compliant None THC BioMed Ltd. Targeted – random testingFootnote 4 N/A Compliant None Tilray Targeted Minor Compliant None Tweed Farms Inc. Annual Minor N/A None Tweed Inc. Annual Minor

Major Compliant None WeedMD Pre-sales N/A N/A None Inspection Data Summary September 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Agripharm Corp. Targeted Minor Compliant None Aphria Pre-sales N/A N/A N/A Aurora Cannabis Enterprises Inc. Targeted Minor Compliant None Aurora Cannabis Enterprises Inc. Targeted – random testingFootnote 4 N/A N/A None Beleave Kannabis Corp. [previously First Access Medical Inc.] Targeted Minor Compliant None Canna Farms Ltd. Targeted Minor Compliant None DelShen Therapeutics Corp. Targeted Minor

Major Compliant None Maricann Inc. Targeted No Compliant None Natural Med Company Targeted Minor

Major

Critical Non-CompliantFootnote 1 Warning letter issued due to non-compliance with the Good Production PracticesFootnote 2 OrganiGram Inc. Targeted Minor Compliant None Peace Naturals Project Inc. Pre-sales N/A N/A N/A United Greeneries Ltd. Pre-sales N/A N/A N/A UP Cannabis Inc. Pre-sales N/A N/A N/A UP Cannabis Inc. Annual Minor

Major Compliant None WeedMD Targeted Minor

Major Compliant None Whistler Medical Marijuana Corp. Annual Minor

Major Compliant None Whistler Medical Marijuana Corp. Pre-sales N/A N/A N/A Inspection Data Summary August 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions 7 Acres Targeted Minor Compliant None Acreage Pharms Ltd. Targeted Minor

Major Compliant None Bedrocan Canada Inc. (2nd site) Targeted Minor Compliant None Delta 9 Bio-Tech Inc. Targeted Minor Compliant None Emerald Health Therapeutics Canada Inc. Annual Minor

Major Compliant None Green Relief Inc. Targeted Minor Compliant None Hydropothecary Annual Minor Compliant None International Herbs Medical Marijuana Ltd. Targeted No Compliant None MedReleaf Corp. Targeted Minor Compliant None Northern Lights Marijuana Company Ltd. Targeted Minor Compliant None Peace Naturals Project Inc. Annual Minor

Major Compliant None Spectrum Cannabis Canada Ltd. [previously Mettrum Ltd.] Annual Minor Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Annual Minor Compliant None Tantalus Lab Ltd. Targeted Minor Compliant None Tweed Grasslands Cannabis Inc., [previously rTrees Producers Lmited] Targeted Minor Compliant None Inspection Data Summary July 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions A B Laboratories Annual Minor

Major Compliant None ABcann Medicinals Inc. Regular Minor

Major Compliant None Bedrocan Canada Inc. Annual Minor Compliant None Bonify Medical Cannabis Targeted Minor Compliant None Broken Coast Cannabis Ltd. Targeted – random testingFootnote 4 Footnote 5 N/A N/A None Canada's Island Garden Inc. Targeted Minor Compliant None CannTrust Inc. Targeted Minor

Major Compliant None Emblem Cannabis Corp. Annual Minor

Major Compliant None Evergreen Medicinal Supply Inc. Targeted Minor Compliant None James E. Wagner Cultivation Ltd. Targeted Minor

Major Compliant None MedReleaf Corp. (2nd site) Targeted Minor Compliant None Original BC Ltd. [previously In The Zone Produce Ltd.] Targeted Minor Compliant None Peace Naturals Project Inc. Targeted No Compliant None Sundial Growers Inc. Targeted Minor Compliant None THC Biomed Ltd. Targeted Minor Compliant None The Green Organic Dutchman Ltd. Initial N/A N/A N/A The Green Organic Dutchman Ltd. Targeted Minor

Major Compliant None Tilray Targeted – random testingFootnote 4 N/A N/A None Tweed Farms Inc. Targeted Minor Compliant None Inspection Data Summary June 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Acreage Pharms Ltd. Targeted Minor Compliant None Aphria Regular Minor

Major Compliant None Aurora Cannabis Enterprise Inc. Targeted No Compliant None Beleave Kannabis Corp. [previously First Access Medical Inc.] Targeted Minor Compliant None Broken Coast Cannabis Ltd. Targeted Minor Compliant None Canna Farms Ltd. Targeted Minor Compliant None CanniMed Ltd. Regular Minor Compliant None CannTrust Inc. Initial N/A N/A N/A DelShen Therapeutics Corp. Targeted Minor Compliant None Emblem Cannabis Corp. Initial N/A N/A N/A Hydropothecary Targeted Minor Compliant None Natural Med Company Targeted Minor Compliant None OrganiGram Inc. Targeted Minor Compliant None Prairie Plant System Inc. Targeted Minor Compliant None Peace Naturals Project Inc. Targeted Minor

Major Compliant None RedeCan Pharm Targeted Minor

Major Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Targeted Minor Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Initial N/A N/A N/A Tilray Regular Minor Compliant None Tweed Inc. Targeted Minor

Major Compliant None UP Cannabis Inc. Targeted Minor Compliant None Inspection Data Summary May 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions 7 Acres Targeted Major Compliant None A B Laboratories Targeted Minor

Major Compliant None ABcann Medicinals Inc. Targeted Minor Compliant None Agripharm Corp. Targeted Minor Compliant None Aphria Targeted No Compliant None Canada's Island Garden Inc. Targeted Minor Compliant None CannTrust Inc. Pre-licence N/A N/A N/A Delta 9 Bio-Tech Inc. Regular Minor

Major Compliant None Emerald Health Therapeutics Canada Inc. Targeted Minor Compliant None Evergreen Medicinal Supply Inc. Targeted Minor Compliant None Green Relief Inc. Targeted Minor

Major Compliant None Original BC Ltd. [previously In The Zone Produce Ltd.] Targeted Minor Compliant None MedReleaf Corp. Targeted Minor Compliant None MedReleaf Corp. Pre-licence N/A N/A N/A Northern Lights Marijuana Company Ltd. Pre-licence N/A N/A N/A OrganiGram Inc. Targeted No Compliant None Spectrum Cannabis Canada Ltd. (previously Mettrum Ltd.) Targeted Minor

Major Compliant None THC Biomed Ltd. Targeted Minor Compliant None The Green Organic Dutchman Ltd. Regular Minor

Major Compliant None United Greeneries Ltd. Targeted Minor Compliant None WeedMD Targeted Minor

Major Compliant None Inspection Data Summary April 2017 Licensed producer / applicant Inspection type Observations Inspection rating Significant compliance actions Aphria Targeted Minor Compliant None Aphria Pre-licence N/A N/A N/A Aurora Cannabis Enterprises Inc. Regular Minor

Major Compliant Warning letter issued and seizure of products due to a contravention of Physical Security DirectiveFootnote 2 Footnote 3 Aurora Cannabis Enterprises Inc. Pre-licence N/A N/A N/A Bedrocan Canada Inc. Targeted No Compliant None Bedrocan Canada Inc. (2nd site) Pre-licence N/A N/A N/A Bedrocan Canada Inc. (2nd site) Targeted Minor

Major Compliant None CannTrust Inc. Targeted No Compliant None Emblem Cannabis Corp. Targeted No Compliant None Hydropothecary Targeted Minor Compliant None International Herbs Medical Marijuana Ltd. Pre-licence N/A N/A N/A James E. Wagner Cultivation Ltd. Targeted Minor Compliant None Maricann Inc. Targeted Minor Compliant None Natural Med Company Regular Minor

Major Non-compliantFootnote 1 Warning Letter issued due to non-compliance with the Good Production PracticesFootnote 2 Natural Med Company Initial N/A N/A N/A Natural Med Company Initial N/A N/A N/A OrganiGram Inc. Targeted Minor Compliant None OrganiGram Inc. Pre-licence N/A N/A N/A RedeCan Pharm Regular Minor Compliant None Starseed Medicinal Inc. [previously Mettrum (Bennett North) Ltd.] Targeted Minor

Major Compliant None Tantalus Labs Ltd. Pre-licence N/A N/A N/A Tilray Initial N/A N/A N/A Tweed Farms Inc. Targeted Minor Compliant None Up Cannabis Inc. Targeted Minor Compliant None Whistler Medical Marijuana Corp. Targeted No Compliant None

Fiscal Year 2016-2017

Changes to the Quarterly Inspection Data Summary

The reporting format of the Quarterly Inspection Data Summary has been changed from the 2015-2016 publication. The change reflects the implementation of the Inspection Risk-Rating System.

The OMC piloted the Inspection Risk-Rating System in Fiscal Year 2015-2016. This system, implemented on April 1, 2016, establishes a risk-rating for licensed producers based on the observation and inspection rating throughout their licensing period and based on their compliance history. All licensed producers are now evaluated under this Inspection Risk- Rating System.

Observations made during inspections of licensed producers are assigned a minor, major or critical rating. Based on the observation number and severity, an inspection rating of compliant or non-compliant will be given. The inspection rating is used at licence renewal and throughout the licensing period to assess the licensed producer's risk rating. The licensed producer's risk rating is used to determine, among other things, the period of license renewal and the frequency of inspections.

This publication will continue to make more information on compliance and enforcement activities available to Canadians.

Inspection Types

Health Canada conducts four types of inspections to assess and monitor compliance with the ACMPR, CDSA and FDA.

Pre-licence inspection

Conducted to assess whether the information submitted to Health Canada in a licence application or amendment is accurate.

Conducted to assess whether the information submitted to Health Canada in a licence application or amendment is accurate. Initial inspection

Conducted when cannabis is ready for sale and testing is completed to assess whether the facilities, activities, and products are in compliance with the good production practices and record keeping requirements.

Conducted when cannabis is ready for sale and testing is completed to assess whether the facilities, activities, and products are in compliance with the good production practices and record keeping requirements. Targeted inspection

Conducted to verify compliance with particular areas of the ACMPR.

Conducted to verify compliance with particular areas of the ACMPR. Regular inspection

Conducted to monitor and verify compliance with all the requirements of the ACMPR, CDSA and FDA prior to licence renewal.

Observations

An observation is a deficiency or deviation from legislative or regulatory requirements noted by an inspector during an inspection and is classified as minor, major, or critical.

Pre-licence and initial inspections assess the applicant's or the licensed producer's readiness for conducting various activities outlined within an application. Therefore, observations are not rated during these inspections.

Minor

Minor observations will likely not increase the risk of diversion, prevent the detection of diversion, and/or health risk.

Minor observations will likely not increase the risk of diversion, prevent the detection of diversion, and/or health risk. Major

Major observations may increase the risk of diversion, prevent the detection of diversion, and/or health risk.

Major observations may increase the risk of diversion, prevent the detection of diversion, and/or health risk. Critical

Critical observations will likely increase the risk of diversion, prevent the detection of diversion, and/or present an imminent health risk, and may also involve the possibility of deliberate fraud, misinterpretation, or falsification of information.

Inspection Rating

An inspection can be assigned a compliant or non-compliant rating based on the number and severity of observations noted during an inspection. It should be noted that a compliant inspection rating may be assigned when observations are present.

Pre-licence and initial inspections are not assigned inspection ratings since observations are not rated.

Compliant

A compliant inspection rating means that at the time of the inspection, the licensed producer has met the applicable legislative and regulatory requirements, and is in control of the regulated activities.

A compliant inspection rating means that at the time of the inspection, the licensed producer has met the applicable legislative and regulatory requirements, and is in control of the regulated activities. Non-Compliant

A non-compliant inspection rating means that at the time of the inspection, the licensed producer has not met the applicable legislative and regulatory requirements, and is not in control of the regulated activities.

Significant Compliance Actions

A significant compliance action is taken to correct instances of non-compliance. These may include, but are not limited to, issuance of warning letters, seizure and detention of products, licence suspension or revocations.

It is important to note that a licensed producer may have had a significant compliance action with a compliant inspection rating. This is possible due to the corrective measures taken to address the non-compliance and prevent any future non-compliance.

Inspection Data

The following table presents inspection data by the month in which they were conducted.

All inspections from April 1, 2016 to August 23, 2016 were conducted under the Marihuana for Medical Purposes Regulations. As of August 24, 2016, all inspections will be conducted under the ACMPR.

Fiscal Year 2015-2016

Types of Inspections

Health Canada conducts four types of inspections to assess and monitor compliance with the MMPR, CDSA and FDA.

Pre-licence inspection is conducted to verify that the information submitted to Health Canada in a licence application or amendment is accurate prior to licence approval.

is conducted to verify that the information submitted to Health Canada in a licence application or amendment is accurate prior to licence approval. Initial inspection is conducted when marijuana is ready for sale and testing is completed to verify that the facilities, activities, and products are in compliance with the good production practices and record keeping requirements.

is conducted when marijuana is ready for sale and testing is completed to verify that the facilities, activities, and products are in compliance with the good production practices and record keeping requirements. Targeted inspection is conducted to verify compliance with particular areas of the MMPR.

is conducted to verify compliance with particular areas of the MMPR. Regular inspection is conducted to monitor and verify compliance with all the requirements MMPR and CDSA prior to licence renewal.

Observations

An observation is a deficiency or deviation from legislative or regulatory requirements noted by an inspector during an inspection and is classified as critical or non-critical.

Critical observations are non-compliances that may pose a risk: of diversion; to the health and safety of medical users; security of the site, and/or confidence of Canadians in the marijuana product or the MMPR program.

are non-compliances that may pose a risk: of diversion; to the health and safety of medical users; security of the site, and/or confidence of Canadians in the marijuana product or the MMPR program. Non-critical observations are less likely to have a serious impact on the critical risks for marijuana production.

The scope and severity of the deficiency or deviation from the requirements of the CDSA or the MMPR will be assessed by the inspector in the context of the inspection being conducted and may result in significant compliance actions where necessary.

Significant compliance actions are classified as warning letters, detention, seizure, licence suspension or revocations.

Inspection Data (2015-2016)

The following table presents inspection data by the month in which they were conducted.

Critical observations do not always initiate a significant compliance action. In the 2015-2016 inspection system, significant compliance actions are undertaken based on the compliance history of the licensed producer, and the severity and number of observations present during a given inspection. For example, an inspector notes that there is an instance when there is no Responsible Person In Charge in an area where cannabis is present. This would be cited in the inspection report as a critical observation. The licensed producer may advise Health Canada that they will address this citation by ensuring that all staff follow the required standard operating procedures. As the critical observation has been addressed by the licensed producer through a proposed corrective action plan, no significant compliance actions by Health Canada will be taken.

Cannabis for Medical Purposes

Monthly Compliance and Enforcement Report - Inspection Data Summary 2015-2016 Licensed Producer / Applicant Inspection Type Observations Significant Compliance Actions Critical Non-Critical Mar-2016 ABcann Medicinals Inc. Targeted No Yes None Aphria Targeted Yes Yes None Aphria Pre-Licence N/A N/A None Agripharm Corp. Targeted Yes No None Aurora Cannabis Enterprises Inc. Targeted No Yes None Bedrocan Canada Inc. Targeted No Yes None Broken Coast Cannabis Ltd. Targeted Yes No None Canna Farms Ltd. Targeted No Yes None CannTrust Inc. Targeted No Yes None Canveda Inc. Pre-Licence N/A N/A None Delta 9 Bio-Tech Inc. Targeted No Yes None Emblem Cannabis Corp. (previously KindCann Limited) Targeted No Yes None Hydropothicaire / Hydropothecary Targeted No Yes None In the Zone Produce Ltd. Targeted No No None MariCann Inc. Targeted No Yes None MedReleaf Corp. Targeted Yes Yes None Mettrum Ltd. (Bennett North) Targeted No Yes None Mettrum Ltd. Targeted No Yes None OrganiGram Inc. Targeted No Yes None OrganiGram Inc. Pre-Licence N/A N/A None RedeCan Pharm Regular No Yes None Sundial Growers Inc. Pre-Licence N/A N/A None THC Biomed Ltd. Targeted No No None Tilray Targeted Yes Yes None Tweed Farms Inc. Targeted No Yes None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted No Yes None Feb-2016 ABcann Medicinals Inc. Targeted No Yes None Agripharm Corp. Targeted Yes No None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Targeted Yes Yes Seizure of products due to Good Production Practices non-compliance Aurora Cannabis Enterprises Inc. Pre-Licence N/A N/A None Bedrocan Canada Inc. Targeted No Yes None Bedrocan Canada Inc. (2ndsite) Targeted Yes Yes None Broken Coast Cannabis Ltd. Targeted No No None Canna Farms Ltd. Initial N/A N/A None CannTrust Inc. Pre-Licence N/A N/A None CannTrust Inc. Targeted Yes Yes Seizure of products due to contravention of Physical Security Directive



Issuance of a warning letter for non-compliance Delta 9 Bio-Tech Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Targeted Yes Yes None Hydropothicaire / Hydropothecary Targeted Yes No None In the Zone Produce Ltd. Targeted No No None Emblem Cannabis Corp. (previously KindCann Limited) Targeted No Yes None MariCann Inc. Targeted Yes Yes None MariCann Inc. Pre-Licence N/A N/A None MedReleaf Corp. Targeted Yes No None Mettrum Ltd. (Bennett North) Targeted No Yes None Mettrum Ltd. Targeted Yes Yes None OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc Targeted Yes No None Prairie Plant Systems Inc. Pre-Licence N/A N/A None RedeCan Pharm Targeted No Yes None Tilray Targeted Yes Yes None Tweed Farms Inc. Pre-Licence N/A N/A None Tweed Inc. Targeted Yes No None United Greeneries Ltd. Pre-Licence N/A N/A None Whistler Medical Marijuana Corp. Targeted No Yes None Jan-2016 ABcann Medicinals Inc. Regular Yes Yes None Agripharm Corp. Targeted Yes Yes None Aphria Pre-Licence N/A N/A None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Targeted No Yes None Bedrocan Canada Inc. Targeted No Yes None Bedrocan Canada Inc. (2ndsite) Targeted Yes Yes None Broken Coast Cannabis Ltd. Regular Yes Yes None Canna Farms Ltd. Targeted No No None CannTrust Inc. Initial N/A N/A None CannTrust Inc. Regular Yes Yes None Delta 9 Bio-Tech Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Targeted No No None Hydropothicaire / Hydropothecary Targeted Yes No None In the Zone Produce Ltd. Targeted No No None Emblem Cannabis Corp. (previously KindCann Limited) Targeted Yes No None MariCann Inc. Regular Yes Yes None MedReleaf Corp. Targeted Yes Yes None MedReleaf Corp. Pre-Licence N/A N/A None Mettrum Ltd. (Bennett North) Targeted Yes Yes None OrganiGram Inc. Regular Yes Yes None Peace Naturals Project Inc Targeted Yes Yes None Prairie Plant Systems Inc. Targeted Yes Yes None RedeCan Pharm Targeted No Yes None Tilray Targeted Yes Yes None Tweed Farms Inc. Targeted Yes Yes None Tweed Inc. Targeted Yes Yes None Tweed Inc. Initial N/A N/A None WeedMD Pre-Licence N/A N/A None Whistler Medical Marijuana Corp. Initial N/A N/A None Dec-2015 ABcann Medicinals Inc. Initial N/A N/A None AMMCan Pre-Licence N/A N/A None Agripharm Corp. Initial N/A N/A None Aphria Targeted No Yes None Aurora Cannabis Enterprises Inc. Targeted Yes No None Bedrocan Canada Inc. Targeted Yes No None Bedrocan Canada Inc. (2nd site) Regular Yes Yes None Broken Coast Cannabis Ltd. Targeted No Yes None Canna Farms Ltd. Targeted Yes Yes None CanniMed Ltd. Initial N/A N/A None CannTrust Inc. Targeted Yes Yes Warning letter for contravention of Physical Security Directive Delta 9 Bio-Tech Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Targeted Yes No None Emerald Health Botanicals Inc. Pre-Licence N/A N/A None Hydropothicaire / Hydropothecary Targeted No Yes None KindCann Ltd. Targeted Yes No None MariCann Inc. Targeted Yes Yes None MedReleaf Corp. Regular Yes Yes None MedReleaf Corp. Pre-Licence N/A N/A None Mettrum Ltd. (Bennett North) Initial N/A N/A None OrganiGram Inc. Pre-Licence N/A N/A None OrganiGram Inc. Targeted No Yes None Peace Naturals Project Inc Targeted Yes Yes None RedeCan Pharm Targeted Yes No Warning letter for contravention of Physical Security Directive RedeCan Pharm Targeted No No None Tilray Pre-Licence N/A N/A None Tilray Initial N/A N/A None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None Nov-2015 ABcann Medicinals Inc. Targeted No Yes None ABcann Medicinals Inc. Pre-Licence N/A N/A None Agripharm Corp. Regular Yes Yes None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Initial N/A N/A None Bedrocan Canada Inc. (2nd site) Targeted Yes No None Bedrocan Canada Inc. Regular Yes Yes None Broken Coast Cannabis Ltd. Targeted Yes Yes None Canna Farms Ltd. Regular Yes Yes None CannTrust Inc. Targeted No Yes None Delta 9 Bio-Tech Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Targeted Yes Yes None Green Relief Inc. Pre-Licence N/A N/A None Hydropothicaire / Hydropothecary Targeted Yes Yes None In The Zone Produce Ltd. Pre-Licence N/A N/A None KindCann Ltd. Targeted Yes Yes None MariCann Inc. Targeted Yes No None MedReleaf Corp. Targeted Yes Yes None Mettrum Ltd. (Bennett North) Targeted No Yes None Mettrum Ltd. Pre-Licence N/A N/A None OrganiGram Inc. Targeted No No None Peace Naturals Project Inc Targeted Yes Yes None Prairie Plant Systems Inc. Targeted Yes Yes None RedeCan Pharm Targeted No Yes None Tilray Targeted Yes No None Tweed Farms Inc. Regular Yes Yes None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None Oct-2015 ABcann Medicinals Inc. Targeted Yes Yes None ABcann Medicinals Inc. Pre-Licence N/A N/A None Agripharm Corp. Targeted Yes No None Aphria Targeted Yes No Seizure of products due to Good Production Practices non-compliance Aurora Cannabis Enterprises Inc. Targeted Yes No None Bedrocan Canada Inc. Targeted Yes Yes None Bedrocan Canada Inc. (2nd site) Targeted Yes Yes None Broken Coast Cannabis Ltd. Targeted Yes Yes None Canna Farms Ltd. Targeted Yes Yes None CanniMed Ltd. Regular Yes Yes None CannTrust Inc. Targeted Yes No None Delta 9 Bio-Tech Inc. Targeted Yes No None Emerald Health Botanicals Inc. Regular Yes Yes Seizure of products due to Good Production Practices non-compliance Hydropothicaire / Hydropothecary Targeted Yes No None KindCann Ltd. Targeted Yes No None MariCann Inc. Targeted Yes No None MariCann Inc. Pre-Licence N/A N/A None MariCann Inc. Targeted Yes Yes None MedReleaf Corp. Targeted Yes No None Mettrum Ltd. (Bennett North) Targeted Yes Yes None OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc Initial N/A N/A None Peace Naturals Project Inc Targeted Yes Yes None Prairie Plant Systems Inc. Targeted Yes No None RedeCan Pharm Targeted Yes Yes None Tilray Targeted Yes No None Tweed Farms Inc. Targeted Yes Yes None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None Sep-2015 ABcann Medicinals Inc. Regular Yes Yes None Agripharm Corp. Targeted Yes Yes None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Pre-Licence N/A N/A None Aurora Cannabis Enterprises Inc. Initial N/A N/A None Aurora Cannabis Enterprises Inc. Regular Yes No None Bedrocan Canada Inc. Targeted Yes Yes None Bedrocan Canada Inc. (2ndsite) Targeted Yes No None Broken Coast Cannabis Ltd. Targeted Yes Yes None Canna Farms Ltd. Targeted Yes Yes None CannTrust Inc. Targeted Yes Yes None Delta 9 Bio-Tech Inc. Targeted Yes No None Emerald Health Botanicals Inc. Targeted Yes Yes None Emerald Health Botanicals Inc. Pre-Licence N/A N/A None Hydropothicaire / Hydropothecary Regular Yes No None Hydropothicaire / Hydropothecary Targeted Yes No None MedReleaf Corp. Targeted Yes Yes None Mettrum Ltd. (Bennett North) Regular Yes No None OrganiGram Inc. Targeted No No None Peace Naturals Project Inc. Regular Yes No None Peace Naturals Project Inc. Pre-Licence N/A N/A None RedeCan Pharm Targeted No Yes None Tilray Targeted Yes Yes None Tweed Farms Inc. Targeted Yes Yes None Tweed Inc. Regular Yes Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None Aug-2015 Agripharm Corp. Targeted Yes No None Aphria Pre-Licence N/A N/A None Aphria Regular Yes No None Aurora Cannabis Enterprises Inc. Pre-Licence N/A N/A None Aurora Cannabis Enterprises Inc. Targeted Yes Yes None Bedrocan Canada Inc. Targeted No No None Bedrocan Canada Inc. (2nd site) Targeted Yes No None Broken Coast Cannabis Ltd. Targeted Yes Yes None Canna Farms Ltd. Targeted Yes Yes None CannTrust Inc. Targeted Yes No None Delta 9 Bio-Tech Inc. Regular Yes Yes None Emerald Health Botanicals Inc. Targeted Yes Yes None Hydropothicaire / Hydropothecary Regular Yes No None In the Zone Produce Ltd. Targeted No No None MariCann Inc. Targeted Yes No None MedReleaf Corp. Targeted Yes Yes None Mettrum Ltd. (Bennett North) Targeted Yes No None OrganiGram Inc. Pre-Licence N/A N/A None OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc. Targeted Yes No None Prairie Plant Systems Inc. Pre-Licence N/A N/A None RedeCan Pharm Targeted Yes Yes None THC Medical Systems Ltd. Pre-Licence N/A N/A None Tilray Pre-Licence N/A N/A None Tweed Farms Inc. Pre-Licence N/A N/A None Tweed Farms Inc. Targeted No Yes None Tweed Inc. Pre-licence N/A N/A None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None Jul-2015 ABcann Medicinals Inc. Targeted Yes Yes None Agripharm Corp. Pre-Licence N/A N/A None Bedrocan Canada Inc. (2nd site) Initial N/A N/A None Bedrocan Canada Inc. (2nd site) Pre-Licence N/A N/A None Broken Coast Cannabis Ltd. Pre-Licence N/A N/A None CannTrust Inc. Pre-Licence N/A N/A None Hydropothicaire / Hydropothecary Pre-Licence N/A N/A None KindCann Limited Pre-Licence N/A N/A None MariCann Inc. Pre-Licence N/A N/A None MedReleaf Corp. Pre-Licence N/A N/A None Tilray Regular Yes Yes None Whistler Medical Marijuana Corp. Regular Yes Yes None Jun-2015 ABcann Medicinals Inc. Targeted No No None ABcann Medicinals Inc. Pre-Licence N/A N/A None Agripharm Corp. Initial N/A N/A None Agripharm Corp. Targeted Yes No None Agripharm Corp. Pre-Licence N/A N/A None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Targeted Yes No None Bedrocan Canada Inc. Targeted No Yes None Bedrocan Canada Inc. (2nd site) Targeted No Yes None Broken Coast Cannabis Ltd. Targeted No Yes None Canna Farms Ltd. Targeted Yes Yes None CannTrust Inc. Targeted Yes No None Delta 9 Bio-Tech Inc. Targeted Yes No None Emerald Health Botanicals Inc. Targeted Yes Yes None Hydropothicaire / Hydropothecary Targeted Yes Yes None MariCann Inc. Targeted Yes No None MedReleaf Corp. Targeted Yes No None Mettrum Ltd. (Bennett North) Targeted Yes Yes None OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc. Targeted Yes No None Prairie Plant Systems Inc. Targeted Yes Yes None RedeCan Pharm Regular Yes Yes None RedeCan Pharm Pre-Licence N/A N/A None Tilray Targeted Yes No None Tweed Farms Inc. Targeted No Yes None Whistler Medical Marijuana Corp. Targeted Yes Yes None May-2015 ABcann Medicinals Inc. Targeted Yes No None Agripharm Corp. Regular Yes Yes None Aphria Targeted Yes Yes None Aurora Cannabis Enterprises Inc. Targeted Yes No None Bedrocan Canada Inc. Targeted Yes Yes None Bedrocan Canada Inc. (2nd site) Pre-Licence N/A N/A None Bedrocan Canada Inc. (2nd site) Targeted Yes Yes None Broken Coast Cannabis Ltd. Targeted No No None Canna Farms Ltd. Targeted No No None CannTrust Inc. Targeted Yes No None Delta 9 Bio-Tech Inc. Targeted No No None Emerald Health Botanicals Inc. Targeted No No None Hydropothicaire / Hydropothecary Targeted No No None In the Zone Produce Ltd. Targeted No No None MariCann Inc. Targeted Yes No None MedReleaf Corp. Targeted Yes No None Mettrum Ltd. (Bennett North) Targeted No Yes None OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc. Targeted Yes Yes None Prairie Plant Systems Inc. Targeted No No None Tilray Targeted No No None Tweed Farms Inc. Targeted No Yes None Tweed Inc. Targeted Yes Yes None Whistler Medical Marijuana Corp. Targeted No No None Apr-2015 ABcann Medicinals Inc. Targeted Yes No None Agripharm Corp. Targeted Yes Yes None Aphria Targeted Yes No None Aurora Cannabis Enterprises Inc. Targeted No No None Bedrocan Canada Inc. Targeted No Yes None Bedrocan Canada Inc. (2nd site) Targeted Yes No None Broken Coast Cannabis Ltd. Targeted Yes Yes None Canna Farms Ltd. Targeted Yes Yes None CannTrust Inc. Targeted Yes Yes None Delta 9 Bio-Tech Inc. Targeted Yes No None Emerald Health Botanicals Inc. Initial N/A N/A None Hydropothicaire / Hydropothecary Initial N/A N/A None Hydropothicaire / Hydropothecary Targeted Yes No None MariCann Inc. Targeted Yes No None MedReleaf Corp. Targeted Yes No None Mettrum Ltd. (Bennett North) Targeted Yes No Seizure of unauthorized material OrganiGram Inc. Targeted Yes No None Peace Naturals Project Inc. Targeted Yes Yes None Prairie Plant Systems Inc. Targeted Yes No None RedeCan Pharm Targeted Yes No None Tilray Targeted Yes No None Tweed Farms Inc. Targeted No No None Tweed Inc. Targeted Yes No None Whistler Medical Marijuana Corp. Targeted Yes No None