Following an FDA inspection in Fall of 2023 of a bakery facility that manufactures RTE items, a 483 was issued, but never responded to, so a warning letter was issued. The findings included:
- Food Safety Plan gaps in Hazard Analysis in which the known or reasonably foreseeable hazards were not identified related to contamination with environmental pathogens and mycotoxins potentially associated with the flour used as an ingredient; gaps in Preventive Controls including allergen preventive controls not identifying procedures and processes to manage allergen cross contact and package labels not having allergen declarations; and gaps in verification with no environmental monitoring undertaken in the facility.
- GMP violations including lack of handwashing to protect against allergen cross-contact and food contamination; open beverage containers; and sanitation issues of mold-like substance on lights and ceiling and debris buildup on a fan.
