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

Source: https://www.keypedia.com/records/warning_letter/4-c-foods-corp/1acd8736-d883-415a-a5a7-d02c3c5c825a

> FDA WARNING_LETTER for 4 C Foods, Corp. on November 24, 2014. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 4 C Foods, Corp.
- Inspection Date: 2014-11-24
- Product Type: Food
- Office Name: New York District Office
- Summary: 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.

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/4-c-foods-corp/69d3193f-ae82-477b-ae16-d9c6ff8516fb

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d