What did the FDA find wrong with K & S Food Center LLC?

The FDA issued a warning letter citing adulteration, cgmp violations related to their products or manufacturing practices.

Are K & S Food Center LLC products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have adulteration that may affect product safety.

What should I do if I've used K & S Food Center LLC products?

If you have used products from K & S Food Center LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

K & S Food Center LLC FDA Warning (2017)

Name: K & S Food Center LLC FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:23.956968

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 08, 2017

MODERATE SEVERITY New York District Office 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to K & S Food Center LLC on December 08, 2017 citing adulteration, cgmp violations. The letter was issued by New York District Office.

Adulteration CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in K & S Food Center LLC's operations or product claims.

Potential Health Risks

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your refrigerated, Back-Split Salted Mackerel-VP is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

Regulatory Context

The United States Food and Drug Administration (FDA) inspected your warehouse and distribution facility, located at 1420 Park Street, Hartford, CT, 06106 between October 17th, 2017 and October 24th, 2017. During the inspection, our FDA investigator observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page atwww.fda.gov.

Your significant violations are as follows:

Key Entities Identified

21 CFR Part 123 21 CFR 123.6 21 CFR 123.6 Section 402(a)

Frequently Asked Questions

What did the FDA find wrong with K & S Food Center LLC?: The FDA issued a warning letter citing adulteration, cgmp violations related to their products or manufacturing practices.
Are K & S Food Center LLC products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have adulteration that may affect product safety.
What should I do if I've used K & S Food Center LLC products?: If you have used products from K & S Food Center LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.