FDA WARNING_LETTER - Shree Datt Aquaculture Farms - May 16, 2019

On August 22, 2019, the FDA issued a Warning Letter to Shree Datt Aquaculture Farms in India, following an inspection on May 15-16, 2019. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their cooked shrimp adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary deviation identified was an inadequate HACCP plan for "Cooked and Peeled /PD PV/PND/PDTO/PDTO BFLY IQF" products, specifically concerning monitoring procedures for pathogenic bacteria survival during cooking. The plan's monitoring for the critical control point was insufficient: 1. It lacked continuous temperature recording for steam temperature, with only a visual check of recorded data once per day. The FDA recommends continuous temperature recording with daily visual checks. 2. Monitoring belt speed with a stopwatch was deemed inadequate to ensure the product reached the critical limit of 79°C core temperature for the specified time, as it only indicates time in the cooker, not core temperature conformance.

The company's responses from May 30, 2019, and July 20, 2019, including a revised HACCP plan, were deemed inadequate. Shree Datt Aquaculture Farms must respond within fifteen working days