FDA WARNING_LETTER - Keshodwala Foods (Unit 1) - May 23, 2015

On May 22-23, 2015, the FDA inspected Keshodwala Foods in India and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). Despite the firm's responses and a revised HACCP plan, serious deviations persist, rendering their scombroid fish products (Indian mackerel, Spanish mackerel, mahi mahi) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The revised HACCP plan for "Scombroid Fishes" lacks a CCP or multiple CCPs to control histamine formation from cumulative unrefrigerated exposure during processing. FDA recommends including controls for cumulative time fish are exposed to temperatures above 40°F (4.4°C) and for extended ice storage. 2. **Insufficient Critical Limits:** The plan's critical limits at the R.M. Receiving CCP, specifically "(b)(4)", are inadequate for controlling histamine. There is no critical limit for decomposition; FDA recommends a sensory examination showing decomposition in less than 2.5% of fish. Temperature limits are insufficient for controlling histamine during transport from harvest vessel to plant; FDA recommends specific transit controls for refrigerated, iced, or chemically cooled fish. 3. **Deficient Monitoring Procedures:** Monitoring procedures