Citing serious violations related to GMPs, hazard analysis, and preventive controls, FDA issued a 483 to a bakery. Having received no written response, the agency issued the bakery a warning letter with most of the observed findings being repeats from prior regulatory inspections over the past seven years including:
- In addition to not developing or implementing a recall or food safety plan, observations included the lack of identification of and controls for potential hazards for allergen cross contact, along with improper cleaning practices and sesame seeds in products that did not include them as an ingredient; FD&C Yellow #5 color additive which was also not declared on the product label; Salmonella as an environmental pathogen with no monitoring implemented; mycotoxins, despite the use of flour and tree nuts as ingredients.
- Observed GMP concerns included RTE bakery items stored on dirty racks and handled with unclean fabric mittens; food-contact wood baskets and table with splinters and protruding nails and screws; food debris and residues on several food contact surfaces of equipment, including the ice machine and dough forming/rolling equipment; plant construction and cleanliness with rust on the proofer ceiling, standing water and a pitted floor; flying insects on equipment and dough; and floor damage, dust buildup, and leaking sink and ice machine drains.
