K & S Food Center LLC – FDA Warning Letter, Oct 24, 2017

On December 8, 2017, the FDA issued a Warning Letter to K & S Food Center, LLC, following an inspection of their Hartford, CT, facility from October 17-24, 2017. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated, Back-Split Salted Mackerel-VP adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to Implement HACCP Plan Procedures (21 CFR 123.6(b) and (c)(4) & (c)(7)):** * **Receiving CCP:** The firm did not follow monitoring procedures for time/temperature abuse at receiving for pathogen growth, scombrotoxin, and Clostridium botulinum toxin formation. Out of (b)(4) product receipts between 11/1/2016 and 10/19/2017, only one receipt (11/5/2016) had documented monitoring. * **Storage CCP:** The firm failed to monitor cooler temperatures with the specified frequency, lacking records for continuous temperature monitoring device performance. * **Verification Procedures:** The firm did not document verification procedures at the Receiving