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WARNING LETTER

Atlantic Bakery Ltd. d.b.a. Old School Bakery MARCS-CMS 580244 — Jul 12, 2019

Atlantic Bakery Ltd. d.b.a. Old School Bakery - 580244 - 07/12/2019


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. William B. Himmelrich
Recipient Title
Owner
Atlantic Bakery Ltd. d.b.a. Old School Bakery

45 North Congress
Delray Beach, FL 33445
United States

Issuing Office:
Division of Human and Animal Food Operations East IV

466 Avenida Fernández Juncos
San Juan, PR 00901
United States


July 12, 2019

WARNING LETTER

19-HAFE4-WL-08/CMS Case No. 580244

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Mr. William B. Himmelrich, Owner
Atlantic Bakery Ltd. (d.b.a. Old School Bakery)
45 North Congress
Delray Beach, Florida 33445

Dear Mr. Himmelrich:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 45 North Congress, Delray Beach, FL 33445, on December 20, 2018 through February 05, 2019 (dates not all inclusive), where you manufacture Ready-to-Eat (RTE) bakery products, including pastries and breads. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we determined that your food products manufactured in your facility 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 were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. Subsequently, we received your written response dated March 01, 2019, describing corrective actions taken by your firm. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Furthermore, during this inspection, our investigators obtained product labeling and manufacturing records for several of your RTE bakery products. We have reviewed these documents and found the products that you manufacture and distribute are not labeled in accordance with the Code of Federal Regulations, Title 21, Part 101, Food Labeling Regulation (21 CFR Part 101). Therefore, your RTE bakery products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, in that they are not labeled with the mandatory information required by the Act.

Additionally, on March 01, 2019, we received your response addressing the labeling deviations discussed with your firm during inspection and during the closing meeting held on February 05, 2019. We have found your response inadequate in that it is not specific for the corrections you will be implementing to fully correct your labeling issues. Your response indicates that you have developed a solution to list all ingredients and allergens on each item delivered. It is not clear if you are referring to a label, and if this label meets the requirements established in the Act and applicable regulations. There is no graphic evidence submitted along with your response to evaluate your labeling corrective and preventive actions. According to your response, you are working with a software provider to develop a permanent solution for the labeling issues. However, the solution and expected implementation date are not known.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule provides that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)].

Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

The CGMP & PC rule requires a food safety plan (21 CFR § 117.126), which must include the following:

1) The written hazard analysis, as required by § 117.130(a)(2);
2) The written preventive controls, as required by § 117.135(b);
3) The written supply-chain program, as required by subpart G;
4) The written recall plan, as required by § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
6) The written corrective action procedures, as required by § 117.150(a)(1); and
7) The written verification procedures, as required by § 117.165(b).

Food Safety Plan
You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility (including Crisp Sundried Tomato Cheese Bread, Crisp Cinnamon Bread, Challah Bun Round Plain, Potato Bun, and Brioche Bun products), as required by 21 CFR 117.126(a)(1). Your food products may have biological, chemicals (i.e., mycotoxins), and physical hazards which could require process, allergen, sanitation, and supplier controls.

In your written response, you indicate that you plan to contact the University of Florida to assist you in drafting the Food Safety Plan for your facility, as required by the regulation. We will assess the adequacy and implementation of your Food Safety Plan during the next FDA inspection.

Hazard Analysis
You did not conduct a hazard analysis for any of your products. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,

a. You did not identify allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment.

b. You did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a treatment or otherwise include a control measure (such as, a formulation lethal to the pathogen) that would significantly minimize the pathogen. After products undergo a lethal treatment in the oven, they are exposed to the environment (such as, on metal rack shelves or baking sheets) before being packaged.

c. You did not identify vegetative pathogens, such as, pathogenic Escherichia coli and/or Salmonella, as a known or reasonably foreseeable hazard to determine whether vegetative pathogens are a hazard requiring a preventive control. Your facility manufactures various products with wheat flour and/or tree nuts (such as, almonds, walnuts, pecans, and pistachios). These ingredients have been associated with pathogens.

d. You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures various products with wheat flour and/or tree nuts (such as, almonds, walnuts, pecans, and pistachios). These ingredients have been associated with mycotoxins.

Preventive Controls

You appear to have hazards requiring preventive controls, but you did not identify and implement preventive controls for any of your products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR § 117.135(a). In addition, you did not establish and implement written procedures for monitoring, written corrective action procedures, or conduct verification activities as required by 21 CFR §§ 117.140 -117.165.

Current Good Manufacturing Practice (Subpart B):

1. You did not maintain your plant in a clean and sanitary condition, as required by 21 CFR § 117.35(a). Specifically, our investigators observed in the Oven and Wrap Rooms finished bread products waiting to be bagged held directly on filthy metal rack shelves; in the Wrap Room, fans with buildup of dust were observed blowing directly onto finished bread products waiting to be bagged; and after the Production Room was cleaned, flour, moisture, cobwebs, and a dead beetle-like insect was observed to be inside the motor head of Mixer #(b)(4)

In your written response, you indicate that these observations have been addressed and monitoring of these issues has been implemented. We will verify the adequacy of this corrective action during our next inspection.

2. You did not take adequate precautions to ensure that production procedures did not contribute to contamination, as required by 21 CFR § 117.80(a)(4), and all person working in direct contact with food conform to hygienic practices, as required by 21 CFR § 117.10(b)1). Specifically, our investigator observed your employee wearing street clothes, slicing food (Cheese Crisp) with bare hands, and resting the sliced product on a tray directly on top of an open trash can. The trash can be a source of physical, biological and/or chemical contamination.

In your written response, you indicate that employees have been retrained and instructed that food can only be placed on appropriate food service tables. We will verify the adequacy of this corrective action during our next inspection.

3. Your equipment and utensils were not designed and constructed to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR § 117.40. Specifically, our investigator observed in your Oven Room, what appears to be (b)(4) boards that according to your employees are used to shape and convey dough. These (b)(4) boards were observed covered in what appears to be flour, were deeply scarred, especially at the corners, and were stored on the shelves of a metal rack that was filthy with apparent cobwebs, dust, and flour. Further, it does not appear that the boards were constructed with food grade materials so that they are acceptable to be used in a food manufacturing environment.

Your written response indicates that your storage rack has been cleaned and the chipped boards were discarded and replaced with new ones already in your inventory. It is unclear whether your new boards are made of the same material as the ones discarded and whether they are made from food grade materials so that they are suitable for a food manufacturing operation.

Misbranding Violations

1. Your Banana Nut Bread, Pistachio Biscotti, Challah Bun Round Not Sliced, and Sundried Tomato Cheese Crisps products are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare individual major food allergens, as required by section 403(w)(1) of the Act.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

􀁸 The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or

􀁸 The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].

Specifically:
􀁸 Your Banana Nut Bread product is manufactured with undeclared wheat, egg, walnuts and milk.
􀁸 Your Pistachio Biscotti product is manufactured with undeclared wheat, pistachios, milk, almonds and egg.
􀁸 Your Challah Bun Round Not Sliced product is manufactured with undeclared wheat, egg milk and soy (soy lecithin).
􀁸 Your Sundried Tomato Cheese Crisps product is manufactured with undeclared wheat and milk.
􀁸 Your Challah Bun Round Not Sliced, Banana Nut Bread, and Sundried Tomato Cheese Crisps products are manufactured with undeclared soybean oil. If your firm is using highly refined soybean oil, then it is not a major allergen; however, if the oil is not highly refined, it must be declared in accordance with section 403(w) of the Act.

2. Your Banana Nut Bread (wholesale), Pistachio Biscotti, and Challah Bun Round Not Sliced products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels, if any, fail to bear the common or usual name of the food as required by 21 CFR 101.3.

3. Your Banana Nut Bread, Pistachio Biscotti, Challah Bun Round Not Sliced, and Sundried Tomato Cheese Crisps products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient and sub-ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, these products are not labeled with an ingredient statement.

4. Your Banana Nut Bread (wholesale and retail), Pistachio Biscotti (retail), Challah Bun Round Not Sliced, and Sundried Tomato Cheese Crisps products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). Specifically:

􀁸 Your Banana Nut Bread (retail) is labeled with your firm’s dba name but not the street address, city, state or zip code.
􀁸 Your Banana Nut Bread (wholesale) is not labeled with the name and place of business of the manufacturer, packer, or distributor.
􀁸 Your Pistachio Biscotti (retail) is labeled with your firm’s dba name, city, and state but not the street address or zip code.
􀁸 Your Challah Bun Round Not Sliced is not labeled with the name and place of business of the manufacturer, packer, or distributor.
􀁸 Your Sundried Tomato Cheese Crisps is not labeled with the name and place of business of the manufacturer, packer, or distributor.

We note that the street address may be omitted if it is shown in a current city directory or telephone directory. Further, in the case of nonconsumer packages, the requirement for listing the zip code may be met with declaration on the label or on the labeling (including invoice).

5. Your Banana Nut Bread, Pistachio Biscotti, and Challah Bun Round Not Sliced products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C.§343(e)(2)] because they fail to bear an accurate statement of the net quantity of contents, as required by 21 CFR 101.7.

6. Your Banana Nut Bread and Pistachio Biscotti, products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the products fail to include a Nutrition Facts label on the product package, as defined in 21 CFR 101.9.

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 CGMP & PC rule, 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 revised procedures, photographs, results of tests you have conducted, and 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 directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.

Sincerely,
/S/

Ramon Hernandez
Director, San Juan District Office, and
Program Division Director,
Office of Human and Animal Food Operations
Division IV East