Gourmet Classic Salads, Inc. – FDA Warning Letter, Jul 10, 2015

The FDA inspected Gourmet Classic Salads, Inc. from June 9 to July 10, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's ready-to-eat seafood salad products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Ready to Eat Seafood Salads" fails to list critical control points for "Processing/mixing and blending" and "Distribution/shipping" to control pathogenic bacteria growth and toxin formation. The firm noted deliveries exceeding four hours. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** The HACCP plan's monitoring procedure for refrigerated storage at the (b)(4) CCP is inappropriate. It relies on a "circular temperature recording device" and a "quick check thermometer" monitored (b)(4) day, which does not provide continuous monitoring or account for non-operational periods. 3. **Failure to Implement Monitoring Procedures (21 CFR 123.