As part of its enforcements, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
In an Oct. 9 warning letter, the FDA used more than 2,600 words to outline “serious violations” at Pollman’s Bake Shops Inc., which is owned by Rose B. and Fred J. Pollman III.
The FDA inspected the company’s bakery and central kitchen facility on June 3-5, and 13. Based on FDA’s inspectional findings the agency determined that food manufactured in the facility is adulterated in that it was prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
Further, the FDA reviewed product labeling and found that the Pollman’s cookies, pies, sweet baked or fried goods, cake, and rolls are misbranded regarding food allergens.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at the operation. As of the date of the warning letter, the FDA had not received a response.
The following points are among the problems found by FDA inspectors and addressed in the warning letter.
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 preventive control. 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 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 E. 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 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 whenever a supplier controls a hazard that requires 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. 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.
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:
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. 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 the 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 boiling 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. 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 (redacted by FDA) 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. 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.
1. Your Cookie, Pie, Sweet Baked or Fried Goods, Cake, and Rolls products are misbranded, in that the finished product labels fail to declare the major food allergens, as required. 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.
Federal law 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.”
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement. The failure to register a facility as required is a prohibited federal law.