Following a 2023 inspection of a restaurant RTE meals manufacturer, the FDA issued the facility a warning letter due to continued concerns with the noted observations. These included:
- Hazard Analysis and Risk-based Preventive Controls issues with
- Environmental pathogen (e.g., Salmonella) recontamination prior to food packaging was not identified or evaluated as a potential hazard, and no sanitation preventive control was identified.
- Allergen cross contact was not identified as a potential hazard, despite the presence of allergen-containing ingredients; procedures to minimize allergen cross contact were not implemented; and allergens were not declared on the finished product labels.
- Biological hazards were not identified, with process preventive controls to minimize bacterial growth or toxin formation not properly implemented.
- Mycotoxins were not identified and evaluated as a potential flour or peanut hazard, and the supply chain control for the wheat flour supplier was incompletely implemented.
- Inadequate GMP observations included improper handwashing, damaged flooring, hose nozzle on the floor, uncovered food items in cooler with condensation present, and Listeria monocytogenes in the facility with evidence of a resident strain.
- No Reportable Food Registry report had been filed for a facility recall.
FDA is serious about regulatory and consumer protection failures noted on a 483 inspection report, and the lack of adequate correction action – and sufficient response to the agency – will, more often than not, result in a Warning Letter.
TAG can assist with both preventive and responsive action. Give us a call to help you prevent or manage a crisis.
