Delivery Method: UPS

Recipient: Recipient Name John D. Gates and Stuart J. Witt Nashoba Brook Bakery, LLC 152 Commonwealth Ave.

Concord, MA 01742-2990

United States Issuing Office: New York District Office United States

Office of Human and Animal Food Operations East

Division 1

WARNING LETTER

CMS# 532236

UNITED PARCEL SERVICE

SIGNATURE REQUIRED

September 22, 2017

John D. Gates, CEO/Co-Owner

Stuart J. Witt, Head Baker/ Co-Owner

Nashoba Brook Bakery, LLC.

152 Commonwealth Ave.

Concord, MA 01742-2990

Dear Mr. Gates and Mr. Witt:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat manufacturing facility located at 152 Commonwealth Ave. Concord, MA, 01742 from May 25 through June 8, 2017. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110]. [1] At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. To date we have not received a written response to the FDA Form 483, List of Inspectional Observations which was issued.

Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products 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 heath.

Additionally, during the inspection our investigators obtained the labels that your firm uses for your Nashoba Granola product. We have reviewed your labels and identified violations of the food labeling regulations, 21 CFR Part 101, which causes the products discussed below to be misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343].

You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov

Your significant violations are as follows:

Adulterated Foods:

1. Your firm failed to conduct all food manufacturing, including packaging and storage, under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically, on May 25 and 26, 2017, our investigator observed the following:

a. On May 26, 2017, remnants of Pepper Jack dough (dairy allergen) were observed on the inside, the lip, and the outside edges of the “ (b)(4) ” stainless steel mixing bowl that an operator stated was cleaned, sanitized and ready for use prior to the production of non-dairy Sourdough dough.

b. On May 25 and 26, 2017, empty color-coded barrels designated for use with different allergens including tree nuts (b)(4) and cheese (b)(4) , with apparent dough residue inside and out, and stacked inside one another. These barrels were confirmed as clean and ready for use by the mixing operator, and were observed in use during operations.

c. On May 25 and 26, 2017, (b)(4) bread loaf molds, wooden peels, canvas conveyor mats, rolling metal wire cooling racks, and ovens are not cleaned or sanitized prior to production or during change-over in between different allergen products. Your firm does not have a procedure or production schedule to ensure cleaning and sanitation is done before production or in between changes to prevent cross-contamination of different allergen products.

We acknowledge that on May 26, 2017 your firm re-cleaned and sanitized the “ (b)(4) ” stainless steel mixing bowl and on June 8, 2017 your firm promised to retrain employees on proper cleaning and sanitizing of the dough mixers and to create a daily cleaning log which would be checked by a supervisor. However, no FDA-483 response has been provided to show employees have been re-trained or systems of verification have been implemented to prevent recurrence.

2. Your firm failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b)(1). Specifically, on May 25 and 26, 2017, our investigator observed the following:

a. What appeared to be an encrusted buildup of brown colored debris on the metal screen of the " (b)(4) " dough mixer that is positioned over all raw dough mixed during its operation.

b. Plastic barrels, barrel lids, totes and tote lids used to hold and transport raw dough with apparent dough residue buildup. One barrel had an approximate 1" dough clump from a different day’s production still stuck in a crack. These barrels had previously been pressure washed and were considered ready for use.

We acknowledge that during the inspection, your firm promised the cleaning schedule for barrels, totes and their lids would change from (b)(4) to being cleaned and sanitized (b)(4) and that your firm stated they will now be monitored for crack formation. However, no FDA-483 response has been provided to show implementation of a new cleaning schedule or how your firm is monitoring barrels for crack formation (e.g. who will perform the monitoring or the frequency of the monitoring checks) in order to prevent recurrence.

3. Your firm failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep in sufficient repair to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). Specifically, on May 25 and 26, 2017, our investigator observed the following in the production area:

a. Two ceiling air intake vents adjacent to the bread ovens and above racks of ready-to-eat foods were caked with apparent debris.

b. Two large wooden bread peels used to pull ready-to-eat breads from ovens were placed on top of the ovens, which were covered with apparent debris.

c. Sprinkler heads above the bread ovens where ready-to-eat foods come out, were caked with apparent debris.

d. Ceiling tiles appeared stained, discolored, and some were missing or damaged.

e. Both food contact and non-food contact surfaces (shelving, production equipment, floors, etc.), had what appeared to be remaining residue of flour buildup after the nightly cleaning was completed.

f. Portions of the floor were damaged and missing.

We acknowledge that during the inspection, your firm hired a new employee who will be responsible for cleaning the facility and that your firm promised to replace missing and damaged ceiling tiles and flooring. However, no FDA-483 response has been provided to document corrective and preventative actions have been taken or implemented.

4. Your firm failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(1). Specifically, on May 25 and 26, 2017, our investigator observed cracked and damaged barrels were used to hold and transport raw dough.

We acknowledge that during the inspection, your firm began purchasing new barrels to replace cracked ones and have replaced (b)(4) cracked or damaged barrels. However, no FDA-483 response has been provided to demonstrate all barrels have been replaced or detailing how your firm will prevent the use of cracked or damaged barrels from recurring in the future.

5. Your firm failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, from May 25 through June 2, 2017, our investigator observed the following:

a. Approximately five flies in the ready-to-eat cooling area and processing area of the facility, all near or on food.

b. One approximately 1" long crawling insect underneath exposed ready-to-eat foods in the pastry area, including focaccia breads, 7-Grain rolls, and brioche rolls.

We acknowledge on May 25, 2017, that once alerted by our investigator that a fly was observed crawling on raw Brioche dough, your firm removed the dough and separated it into a designated animal food area. However, no FDA-483 response has been provided that details corrections for preventing future recurrence.

6. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 110.10(b).

a. Your firm failed to have employees remove unsecured jewelry or other objects which might fall into food, equipment, or containers, as required by 21 CFR 110.10(b)(4). Specifically, on May 25 and 26, 2017, our investigator observed the following:

1. The mixing employee was wearing a blue plastic bracelet while working with raw dough. The bracelet came into repeated contact with raw dough and dough varieties.

2. A production employee wore a nose ring and earrings while handling and shaping raw dough.

b. Your firm failed to confine drinking beverages to areas other than where food may be exposed or where equipment or utensils are washed, as required by 21 CFR 110.10(b)(8). Specifically, on May 25 and 26, 2017, our investigator observed drinking containers, mugs and cans in the cooling, production and mix areas. Additionally, a water cooler was observed being in use in the production area.

We acknowledge that during the inspection, your firm promised to provide re-training to employees and to remove the water cooler from the production area. However, no FDA-483 response has been provided detailing any corrective or preventative actions that may have been implemented.

7. Your firm failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, on June 2, 2017, our investigator observed plastic bread trays stacked outside and partially covered with a tarp, up against the facility wall that your firm stated were in long-term storage.

We acknowledge that during the inspection, your firm promised to individually shrink wrap each stacked column of trays and monitor for pest activity in the area. However, no FDA-483 response has been provided documenting these corrective or preventative actions have been implemented.

Misbranded Foods:

1. Your Nashoba Granola and Whole Wheat Bread (wholesale and retail) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example,

Your Nashoba Granola label lists ingredient "Love". Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.

Your Whole Wheat Bread label lists the ingredient “Natural Sourdough Starter”, but fails to list the sub-ingredients in predominance by weight.

The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in order of predominance in the finished food.

2. Your Nashoba Granola product is misbranded within the meaning of Section 403(q) of the Act [21 U.S. C. 343(q)] because it fails to bear a nutrition facts label in accordance with 21 CFR 101.9. In addition to wholesaling this product, you also sell this product at your retail café using the same wholesale label. (b)(4) .

3. Your Whole Wheat Bread (retail) product is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. 343(g)(1)] because it is a food for which a definition and standard of identity has been prescribed by regulation, but it fails to conform to such definition and standard. The label states “whole wheat” and “slow rise breads from . . . .” Therefore, it is represented as whole wheat bread for which a standard of identity exists under 21 CFR 136.180. Under the standard, the dough must be made exclusively from whole wheat flour. This product contains wheat flour and corn meal. Therefore, it does not meet the standard of identity for whole wheat bread.

4. Your Whole Wheat Bread (wholesale) product is misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the wholesale label fails to include an appropriate statement of identity in accordance with 21 CFR 101.3. Specifically, the label states “Whole Wheat” however, this is not an appropriate name for a baked good. If this product is a bread, roll, or bun, we note that the product does not meet the standard under 21 CFR 136.180 for whole wheat bread, rolls, and buns. Under the standard, the dough must be made exclusively from whole wheat flour. This product contains wheat flour and corn meal.

5. Your Whole Wheat Bread and Nashoba Granola wholesale labels are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. 343(e)(2)] because the labels fail to include a net quantity of contents statement in accordance with 21 CFR 101.7(a).

In addition, we also offer the following comments regarding your labels:

Your firm has chosen to use the new nutrition facts label format on the retail label for your Whole Wheat Bread product, however, it is not in an appropriate format in accordance with 21 CFR 101.9. Specifically, Vitamin D and Potassium are not declared in accordance with 21 CFR 101.9(c)(8)(ii) as revised in the Final Rule dated May 27, 2016.

We note that on the Whole Wheat Bread (retail) label the “Manufactured in a facility . . . .” statement is intervening material in accordance with 21 CFR 101.2(e).

The Whole Wheat Bread (retail) label bears the claim “A hearty whole grain loaf.” However, the product is made of predominantly wheat flour. We note that FDA has a Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements available at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm059088.htm . Questions 7, 9, and 11 from the draft guidance address “whole wheat” products and label claims. Depending on the context in which a "whole grain" statement appears on the label, it could be construed as meaning that the product is "100 percent whole grain." Consumers should be able to look at the ingredient statement to determine whether the predominant or first ingredient listed is a whole grain. We note that wheat flour should not be labeled as a whole grain flour because wheat flour is a synonym of flour (21 CFR 137.105), and thus, the bran and germ have been removed. However, whole wheat flour (21 CFR 137.200) should be considered a whole grain flour because it contains all the parts of the grain, i.e., the bran, endosperm, and germ. We recommend that a product that is labeled "whole grain" or "whole wheat" only be labeled as such when the flour ingredient in the product is made entirely from whole grain flours or whole wheat flour, respectively. As noted previously, there is a standard of identity for whole wheat bread, rolls, and buns. For bread, rolls, and buns, the dough is made from whole wheat flour, brominated whole wheat flour, or a combination of these and no other type of flour is used.

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 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 FDA without further notice, including, without limitation, seizure and injunction.

Section 743 of the Act (21 U.S.C. 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 noncompliance 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 U.S.C. 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 noncompliance 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.

. Please send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactScott R. Izykat 518-453-2314 x1012 or scott.izyk@fda.hhs.gov

Sincerely,

/S/

Ronald Pace

Program Division Director

Office of Human and Animal Food Operations East – Division 1