In a warning letter following the lack of satisfactory response to an inspection’s 483, a Michigan bakery that makes RTE foods was cited for concerns related to their Food Safety Plan including:
- The hazard analysis did not include the potential of recontamination with environmental pathogens where RTE foods were exposed to the environment and sanitation controls in these areas did not include complete instructions or sanitizer concentration. Although the bakery had an environmental monitoring plan in place, the frequency of testing and analytical methods were not clear. Thus, it was concluded that the plan did not effectively verify the effectiveness of sanitation controls.
- A supply-chain preventive control was not properly implemented, as suppliers were not approved, and proper verification activities were not conducted.
- Baking was not properly identified as a process preventive control: parameters for monitoring, corrective actions and verification were not included, and it was unclear when oven calibration was performed.
- Allergen preventive controls did not address the hazard of cross-contact or undeclared allergens: Products with different allergen content were manufactured on shared equipment; allergen information on product labels was not properly monitored and verified; and proper label application was not ensured.
