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WARNING LETTER

Pollman's Bake Shops, Inc. MARCS-CMS 586422 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Rose B. and Fred J. Pollman, III
Recipient Title
Owners
Pollman's Bake Shops, Inc.

750 S. Broad Street
Mobile, AL 36603-1116
United States

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

6751 Steger Drive
Cincinnati, OH 45237-3097
United States


October 9, 2019

Warning Letter 586422

Dear Mr. & Mrs. Pollman:

The U.S. Food and Drug Administration (FDA) inspected your bakery and central kitchen facility, located at 750 South Broad Street, Mobile, Alabama, from June 3 - 5, and 13, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR 117).

During our inspection of your facility, FDA investigators found serious violations of the CGMP & PC rule. Based on FDA’s inspectional findings observed during the inspection, we determined that food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or 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)]. Further, we have reviewed your labeling and found that your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. However, to date we have not received a response.

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

1. You did not conduct a hazard analysis for any of your products. In particular, 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 undeclared allergens due to incorrect labeling and allergen cross-contact as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures multiple products that contain allergens, such as milk, eggs, soy, and wheat, which must be declared on the label. In addition, your facility manufactures multiple products with different allergen profiles on shared equipment.

b. You did not identify environmental pathogens, such as Listeria monocytogenes and Salmonella, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control, as required by 21 CFR § 117.130(c)(1)(ii). Your facility manufactures ready-to-eat food which is exposed to the environment prior to packaging and after the food undergoes a lethal treatment in the oven. 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 if the food is contaminated after it leaves the oven.

c. You did not identify vegetative pathogens, such as pathogenic Escherichia coli and/or Salmonella, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. Your facility manufactures products with wheat flour, an ingredient that has been associated with pathogens such as these.

d. You did not identify mycotoxins as known or reasonably foreseeable hazards to determine whether they are a hazard requiring a preventive control. Your facility manufactures products with wheat flour, an ingredient that has been associated with mycotoxins.

e. You did not identify the physical hazard of metal as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Equipment with metal-to-metal contact during operation may generate metal fragments that could contaminate food.

f. You did not determine whether there is a hazard requiring a supply-chain-applied control for any of your raw materials and other ingredients to determine whether you need a supply-chain program. You are required to implement a supply chain program in accordance with 21 CFR Part 117, subpart G whenever a supplier controls a hazard that requires a preventive control.

2. You did not 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).

3. You did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in your facility, as required by 21 CFR § 117.126(a)(1).

A food safety plan must include the following:

(1) The written hazard analysis, as required by 21 CFR Part 117.130(a)(2);
(2) The written preventive controls, as required by 21 CFR Part 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by 21 CFR Part 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR Part 117.145(a);
(6) The written corrective action procedures, as required by 21 CFR Part 117.150(a)(1); and
(7) The written verification procedures, as required by 21 CFR Part 117.165(b).

Current Good Manufacturing Practice (Subpart B):

1. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically, the following conditions were observed:

 On June 3, 2019, a live fly was sitting on a 7-inch round double layer yellow cake with white icing in the cake icing room.

 On June 5, 2019, a live fly was sitting on a double layer yellow cake with white and yellow icing in the icing room.

 On June 5, 2019, a live roach was crawling on the floor in the bake room during the manufacture of yellow cupcakes.

 On June 5, 2019, eight live flies were in the cake icing room sitting directly on the prep tables. Additionally, four live flies were on the circular swivel cake stands used for turning the cakes while icing is being applied.

 On June 3, 2019 and June 5, 2019, eight dead roaches were in the bake room, and three dead roaches were in the boil room during manufacturing.

2. You did not maintain your buildings, fixtures, and other physical facilities of the 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,

 On June 3, 2019, a steady stream of water flowed from the air-conditioning unit onto the top of two unbaked pies and then onto the floor.

 On June 3, 2019, broken floor tiles were observed throughout the food manufacturing area in the bake room, boil room and storage room. The floor tiles in these areas were holding dirty, standing water.

3. You did not clean and sanitize utensils and equipment as frequently as necessary to protect against allergen cross-contact and contamination of food, as required by 21 CFR 117.35 (d). Specifically,

 On June 3, and 5, 2019, food residues were observed on the production floors throughout the firm; cooking containers were observed rusted and uncleaned from the previous day’s production of red velvet cake; and standing water was next to the rear walk-in cooler adjacent to the wash room.

 On June 5, 2019, the (b)(4) was observed with an encrusted food build-up from the previous days’ production.

4. You did not store cleaned and sanitized portable equipment as necessary to protect food-contact surfaces from allergen cross-contact and from contamination, as required by 21 CFR 117.35(f). Specifically, On June 3, and 5, 2019, cleaned cooking utensils and uncleaned cooking utensils were observed on the same shelves located in between the production area and wash room area.

Misbranding:

1. Your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls 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 the major food allergen, as required by section 403(w)(1) of the Act. Specifically, your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are manufactured with wheat, milk, egg, soy, coconut, peanuts and/or pecans in various combinations. You package all of your Cookie, Pie, Sweet Baked or Fried Goods, and Cake products into cardboard boxes which are unlabeled. You package your Rolls with a label that includes the name of the firm, street addresses, and telephone numbers only.

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)].

2. Your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4.

3. Your Cookie, Pie, Sweet Baked or Fried Goods, and Cake products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food as required by 21 CFR 101.3.

4. Your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because 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, you package your Cookie, Pie, Sweet Baked or Fried Goods, Cake products in a plain cardboard box without any labeling. You package your Rolls with a label that includes the name and street address but does not have the city, state, or zip code.

5. Your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because the product label fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7.

In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd). (b)(3)(A).

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(3)(A)

This letter is not intended to be an all-inclusive list of deficiencies in 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 regulations.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Please include copies of any available documentation demonstrating that corrections have been made.

Section 743 of the FDCA (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, 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 to your facility.

If you have questions regarding the content of this letter you may contact Kimberly A. Dutzek, Compliance Officer, either via telephone at 615-366-7826, or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East