Serious violations of CGMPs and the PC Rule, along with multiple instances of Listeria species in the production environment, of an RTE bakery caused FDA citations, with the facility’s inadequate corrective actions then resulted in a Warning Letter.
Included in the identified issues were uncleaned nonfood contact surfaces with food residue buildup observed on the undersides and outside surfaces of equipment. Additionally food contact surfaces of certain types of utensils and other equipment were not cleaned which could lead to allergen cross contact or microbiological cross contamination. The facility also had unclean shelving and pallet surfaces, pitted floors, an apparent drain backup, and inaccessible areas behind a freezer where dirt and cobwebs were observed.
In relation to personnel practices, handwashing not performed when needed – before workers started their shifts, after each absence from the workstation, and at any time when the hands may have become soiled or contaminated.
When the inadequate maintenance performance was added to all that, it seems the FDA had little choice but to cite the bakery. While the bakery did issue a response to FDA following the initial citations, its responses were not sufficient to alleviate the agency’s concerns, resulting in the Warning Letter and FDA plan to reinspect the plant at a future date.
