The lack of identification and evaluation of mycotoxins as a potential hazard and incomplete implementation of supply chain controls comprised just one area of the FDA findings and cause for a warning letter to a noodle company in Colorado. The company which produces both RTE and NRTE was cited for other Preventive Controls noncompliances:
- An incomplete hazard analysis as it did not cover all types of food at the facility.
- Lack of identification of undeclared allergens as a potential hazard. Some products contain wheat and/or egg.
- No implementation of procedures to minimize allergen cross contact.
- No environmental monitoring or identification or evaluation of recontamination of the food items with environmental pathogens prior to packaging (e.g., with Salmonella) as a potential hazard.
FDA also identified sanitation concerns including procedures not encompassing all equipment and food residue on equipment; GMP concerns including improper handwashing; use of visibly soiled towels; contact of RTE food items with dusty equipment; dead cockroaches; and cracked, pitted and chipped floors. Additionally, the facility was not properly registered.
