After the FDA inspected an RTE dairy facility, they issued a 483; although the dairy responded to the 483, the FDA then issued a Warning Letter, advising the dairy of its continuing concerns, including:
- From environmental swabs FDA collected during their visit Listeria monocytogenes was detected and whole genome sequencing revealed the presence of a resident strain, since the strain had also been previously detected in finished product.
- Additionally, GMP concerns included lack of hand washing and proper glove use after handling of soiled equipment and utensils and before entering post-pasteurization areas; water overspray from high pressure sprayers to contact equipment surfaces; condensate dripping onto packaging film and covered pasteurizers; dry foot sanitizer used inappropriately since the label directions instructed that this was to be dissolved in water; a lack of clear separation between the clean and sailed areas of uniform changing and plant entry; floors in poor condition with cracks and loose debris; and color coded brushes for food contact and nonfood contact areas not properly stored.
- FDA also observed records that were deemed to have been pre-filled and pre-signed.
