FDA WARNING_LETTER - Sally Jackson Cheeses - December 17, 2010

The FDA inspected Sally Jackson Cheeses on December 15-17, 2010, following the collection of cheese samples. Laboratory analysis revealed the presence of *E. coli O157:H7* in aged cow milk cheese, with a strain indistinguishable from one linked to a human illness outbreak. *Listeria monocytogenes* was found in aged raw goat milk cheese and environmental swabs from the cheese room floor, with indistinguishable PFGE patterns suggesting cross-contamination. These findings led to the conclusion that the cheese products were adulterated under Sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to poisonous substances and insanitary conditions. The Warning Letter also cited serious deviations from Current Good Manufacturing Practices (CGMP) (21 CFR Part 110), documented in an FDA Form 483. Deficiencies included inadequate employee handwashing, insufficient cleaning and sanitizing of non-food-contact surfaces (evidenced by mud, manure, and *L. monocytogenes* on the floor), poor facility maintenance (leaks, cracks, peeling paint, pooling water), failure to ensure proper employee hygienic practices and suitable outer garments, use of equipment (cracked cheese molds, wood surfaces) that cannot be properly cleaned, lack of precautions against contamination from insanitary objects, and improper storage of personal belongings. The firm's response to the Form 483 was deemed insufficient, lacking documentation of corrective actions. FDA requires a response within 15 working days, advising on current operating status and providing documented corrective actions to prevent recurrence, warning of potential seizure or injunction if operations resume without compliance. The firm had stated on its website that it closed in December 2010.