An FDA inspection of a noodle manufacturer found that the facility did not have the required food safety plan and had numerous GMP violations.
Specifically noted in the lack of the food safety plan was that biological hazards, including spore and toxin forming bacteria, food allergens, and mycotoxins, were not identified or evaluated as potential hazards. As such, the controls for these hazards were not effectively implemented, including the lack of pH and water activity monitoring, proper process controls, and allergen controls to manage possible cross-contact or mislabeling. Additionally, there was no identification and evaluation of possible contamination with environmental pathogens, such as Listeria monocytogenes, despite the fact that RTE foods are exposed; and preventive controls such as sanitation were not identified.
Included as GMP violations were:
- Lack of conformance to hygienic practices to protect against cross contamination from biological hazards and allergen cross-contact including personnel inadequate hand washing, wearing of jewelry, and storage of a cell phone and other personal belongings in areas where food items were handled and packaged.
- Violations in the design and construction of equipment and utensils and food contact surfaces not cleaned effectively with storage of food on top of cardboard boxes or in cracked dirty and rusty containers, equipment having food residue buildup, and water droplets and drips observed.
- Pests were not excluded from the facility, with observations of flying birds, live flying and worm-like insects, cockroaches, and a dead mouse; and possible pest harborages included the overgrowth of vegetation at the exterior walls and uncovered trash bins.
- The plant was not maintained in a clean and sanitary condition, as observations included residue buildup observed on walls, ceilings, and floors, and pitted and cracked floors.
