FDA WARNING_LETTER - K & S Food Center LLC - October 24, 2017

Record Details

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

Company: K & S Food Center LLC
Inspection Date: October 24, 2017
Product Type: Food
Office: New York District Office
Person: Ronald M. Pace (Program Director)

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ID · 70a489f5-10ae-49e8-b569-f063eeacf854

Violation Codes10

21 CFR 12321 CFR 123.6(g)21 U.S.C. 342(a)(4)21 CFR 123.6(b)21 CFR 123.6(c)(4)21 CFR 123.6(c)(7)21 CFR 123.1021 CFR 123.8(a)(3)21 U.S.C. 379j-3121 U.S.C. 379j-31(a)(2)(B)

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