FDA WARNING_LETTER - 4 C Foods, Corp. - November 24, 2014

The FDA inspected 4C Foods, Corp.'s cheese manufacturing facility in Brooklyn, NY, on October 9-15, 2014, and November 13-24, 2014. Environmental samples collected in October 2014 tested positive for *Salmonella*. A finished product sample of "4C Homestyle Grated Parmesan Cheese" collected on July 22, 2014, also tested positive for *Salmonella*. Whole Genome Sequencing analysis linked the *Salmonella* from the cheese to environmental samples, indicating persistent contamination.

The presence of *Salmonella*, especially on food contact surfaces (shaker plug inserter, cheese filling hopper, cheese dryer gasket), caused the ready-to-eat cheese products to be adulterated under 21 U.S.C. § 342(a)(4). The firm's corrective action plan did not identify the source of *Salmonella*.

Additionally, the November 2014 inspection revealed Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110): 1. Failure to exclude pests (21 CFR 110.35(c)): A live rodent was observed near the bread crumb packaging line. The firm's response lacked documentation of additional pest control efforts or a sanitation supervisor. 2. Failure to protect against contamination (21 CFR 110.