Environmental pathogens considered a hazard requiring a preventive controls - The facility did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard
Environmental monitoring is required - In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Your facility is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.
Need to consider mycotoxins as a hazard in the hazard analysis - The facility did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures RTE bakery products (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, mycotoxins are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in this ingredient. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). This program was not in place.
Allergen labeling is required - The facility’s written hazard analysis considered undeclared allergens; however, the company determined this to be the responsibility of the customer and the consumer. The facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration. Examples - the challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in the staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared. The 12-inch hoagie rolls were staged for distribution in the staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.
Allergen controls for cleaning to prevent cross contact - Allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, the hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day.
The written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by the employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).
GMP Issues
- A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
- A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
- A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
- In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
- Open beverage bottles were observed 1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough; 2) In the pastry area, under preparation tables, while the employees were manipulating in-process products; 3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
- In the cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
- The plant was not maintained in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically: a. the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance, and b. On two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard. The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mena-food-group-llc-673814-08082024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024
