Recipient: Recipient Name Mr. Michael T. McGee New England Confectionery Company, Inc. 135 American Legion Highway

Revere, MA 02151

United States Issuing Office: Center for Food Safety and Applied Nutrition United States

Office of Human and Animal Food Operations East

Division 1

WARNING LETTER

CMS # 545899

VIA UNITED PARCEL SERVICE

DELIVERY SIGNATURE REQUESTED

May 16, 2018

Mr. Michael T. McGee, Chief Executive Officer

New England Confectionery Company, Inc.

135 American Legion Highway

Revere, MA 02151

Dear Mr. McGee:

The U.S. Food and Drug Administration (FDA) inspected your candy manufacturing facility located at 135 American Legion Highway, Revere, MA from November 13, 2017 through December 14, 2017. That inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR 117) (CGMP & PC Rule). The violations included significant evidence of rodent activity and insanitary conditions throughout your facility. Additionally, during this inspection FDA collected three samples that documented rodent evidence throughout the facility. Based on these analyses and findings, we have determined that your candy products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

The inspection resulted in FDA’s issuance of a FDA Form-483, Inspectional Observations, listing the deviations found at your facility at the conclusion of the inspection. We acknowledge your firm’s disposal of approximately 23,000 pounds of corn starch as corrective action to some of FDA’s observations. We also acknowledge receipt of your email correspondence on January 8 and 10, 2018 which included a description of corrective actions you have implemented or plan to implement in response to the observations noted on the FDA-483. These corrective actions are addressed further below.

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food and FDA's regulations through links in FDA's home page at http://www.fda.gov . Your processing facility is subject to the CGMP & PC Rule (21 CFR 117). Section 418 of the Act (21 U.S.C. § 350g) and its implementing regulation in 21 CFR Part 117, requires subject registered food facilities to evaluate hazards that could affect food manufactured, processed, packed, or held by the facility, to identify and implement preventive controls to significantly minimize or prevent such hazards and to provide assurances that the food manufactured, processed, packed, or held by the facility is not adulterated under section 402 of the Act, 21 U.S.C. § 342. The findings described in this letter demonstrate your facility’s sanitation problems and non-compliance with 21 CFR 117. It is a prohibited act under section 301(uu) of the Act (21 U.S.C. § 331(uu)), for the owner, operator, or agent in charge of a facility that manufactures, processes, packs, or holds food for sale in the United States to not comply with section 418 of the Act, as implemented in 21 CFR Part 117. You can find the Act,and FDA's regulations through links in FDA's home page at

During this inspection, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice (CGMP) requirements (subpart B) in the CGMP & PC rule [21 CFR Part 117]:

1. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests as required by 21 CFR 117.35(c). Specifically, during the inspection, FDA investigators noted evidence of rodent activity in the following food storage areas in your facility:

Rodent excreta pellets (REPs) too numerous to count (TNTC) and evidence of wide spread rodent activity were identified in multiple areas throughout the plant, on raw material, and components of ready-to-eat (RTE) product. Specifically, our investigators noted REPs on the floor across from the “Sweethearts” production staging area, the floor of the “Sweethearts” cooling room, the floor of the peanut roasting room between pallets containing empty drums of “Mary Jane Peanut Butter”, in multiple locations on the floor of the raw material storage warehouse, in multiple locations on the floor of the finished product storage warehouse, the floor and storage racks of the second floor maintenance area, in multiple areas on the floor of the molding room and the loading dock. Ripped bags of sugar and ripped bags of almonds appearing to have been re-sealed were observed. Spilled sugar and almonds were observed on the floor. REPs were observed among spilled almonds on the floor.

REPs were identified on trays used make corn starch molds, trays of corn flour used to make molds for RTE caramel cores, trays of corn flour used to make molds for RTE caramel cores for “Mighty MELS”, a pallet of empty plastic trays used to make corn starch molds, a pallet of chocolate gems, racking in the raw material storage warehouse, a pallet of finished product packaging in the finished product storage warehouse, a pallet of sodium bicarbonate, the top of a pallet of corrugate used to package “Sweethearts”, and the outside of a wooden crate used to store unused equipment in the second floor staging area across from the “Sweethearts” production room. Rodent urine stains were observed in multiple areas of the finished product storage warehouse, multiple areas in the raw material storage warehouse, and on storage racks and the floor in the second-floor maintenance area.

Rodent gnaw holes and nesting material were observed in a pallet that contained three cases of chocolate dipped peanuts stored in the finished product storage warehouse. A hole with rodent like gnaw marks, covered with a sticker label, was observed on a bag of corn flour.

On the second floor, across from the “Sweethearts” production staging area, a hole/potential ingress for rodents or other pests, was revealed when the FDA investigator removed a loose brick at the base of a column surrounded by REPs TNTC. REPs TNTC and apparent rodent urine stains were observed on the floor of the raw material storage warehouse where two approximately ½ inch diameter holes/potential ingress for rodents or other pests were located.

A dead rodent which measured approximately 12 inches in length was observed in the parking lot approximately 20 feet south of the employee entrance.

The above observations of apparent REPs in the warehouse storage locations represent repeat observations from the inspection dated 06/07/17 - 06/12/17.

Your firm’s response included rodent reports indicative of active rodent infestation with the regular trapping of live mice and many open repeat conditions as recently as 1/5/18. Review of your exterminator reports during the inspection as early as 7/27/17 noted their assessment as, “There is a significant amount of mice activity in the building.” At this time, we cannot verify the adequacy of your corrective actions. We will evaluate your corrective actions during a future inspection. We note, however, that your response fails to specifically provide changes in your pest control procedures with timeframes for completion.

2. You did not maintain buildings, fixtures, and other physical facilities in your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated as required by 21 CFR 117.35(a). Specifically, FDA investigators observed:

An unknown liquid dripping from a ventilation duct in the “Sweethearts” (730) mixing room adjacent to exposed RTE “Sweethearts.” The liquid was being collected into a 55-gallon drum and two 5-gallon buckets. Moisture was observed on the floor next to the buckets. Employees were observed carrying exposed trays of “Sweethearts” within 6 inches of the dripping liquid to the production line. Additionally, piping and areas of the ceiling directly above the exposed “Sweethearts” had brown stains.

An approximate 8' x 3' puddle of standing liquid in the shipping/receiving area. An employee stated it was from a roof leak.

An approximate 4' x 3' puddle of standing liquid outside of the finished product storage warehouse. An employee stated it was from a roof leak.

These are repeat observations from the prior inspection dated 06/07/17 - 06/12/17.

Additionally, finished products were observed stored in the “Sweethearts” (730) mixing room and wet tracks from fork lift trucks were observed from the puddles leading into the raw material and finished product storage areas. Puddles of standing liquid were observed on the floor of this area.

The room with the sugar pulverizer was noted to be missing several ceiling panels and sugar was observed above the section of ceiling where the ceiling panels were missing. Moisture was observed on the floor and was being soaked up by the sugar on the floor.

Your firm’s response addresses the apparent repair of the ventilation duct on 12/5/17 with no dripping observed. Your response states, “some type of inspection” would be conducted to assure there is no dripping from any ducts, but no timeframes were provided for completion. This response is inadequate in that issues other than the work to repair the ceiling tiles were not addressed.

3. You did not clean and sanitize your utensils and equipment in a manner that protects against the contamination of food as required by 21 CFR 117.35(d). Specifically, after an employee inspected the equipment and determined it was clean, FDA investigators observed apparent food residue on the interior surface of the housing which surrounds the large ribbon blender across from line #5. This surface is directly above food when the blender is in the vertical position. Residue was also observed on the interior surface of the ribbon blender. Residue and “Sweethearts” from a previous day’s production were observed on a conveyor belt leading into the dryer.

Your firm’s response included equipment inspection and pre-op inspection forms which reference checking that equipment and utensils are clean and in good repair. At this time, we cannot verify the adequacy of your corrective actions. We will evaluate your corrective actions during a future inspection. We note, however, that your response did not include accompanying written procedures describing the use of the forms.

4. You did not clean your non-food contact surfaces as frequently as necessary to protect against contamination as required by 21 CFR 117.35(e). Specifically, FDA investigators observed a heavy accumulation of residual food product on the top and sides of extruders used to manufacture, “Necco Wafers” and “Sweethearts”. The surfaces of the extruders also contained a heavy accumulation of dust. Food debris was observed below conveyor belts.

Your firm’s response included equipment inspection and pre-op inspection forms which reference checking that all non-food contact surfaces are free of dust, debris and product. At this time, we cannot verify the adequacy of your corrective actions. We will evaluate your corrective actions during a future inspection. We note, however, that your response did not include written procedures relaying the use of such forms.

5. Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination as required by 21 CFR 117.40. Specifically, FDA investigators observed:

The top belt on dryer #1 appeared to be frayed along the edges with loose material creating the potential for foreign material to enter the product. In addition, an investigator observed what appeared to be pieces of the belt on 2 trays of “Sweethearts” in the “Sweethearts” cooling room.

Plastic trays used for peanut butter “Mary Jane” candy appeared to be frayed along the edges with loose material, creating the potential for foreign material to enter the product.

This is a repeat observation from the inspection dated 06/07/17 - 06/12/17.

Your firm’s response states the sanitation team will be spending four hours on each (b)(4) (a hot air drying tunnel), trimming the belts every day. At this time, we cannot verify the adequacy of your corrective actions. We will evaluate your corrective actions during a future inspection. We note, however, that your response does not include procedures to address replacement of belts and does not address how you will monitor the condition and maintenance of belts.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, found in Title 21 of the Code of Federal Regulations Part 117 (21 CFR 117) and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 USC 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your written response should be sent to: Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.

Sincerely,

/S/

Ronald M. Pace

Program Division Director

Office of Human and Animal Food Operations East – Division 1