FDA WARNING_LETTER - East Bay Seafood Co., Inc. - May 17, 2013

On June 14, 2013, the FDA issued a Warning Letter to East Bay Seafood Co., Inc. following an inspection from May 7-17, 2013, which revealed serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The firm's raw, ready-to-eat tuna was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Failure to take appropriate corrective action (21 CFR 123.7(a)):** The firm accepted a tuna shipment on May 10, 2013, that did not meet its HACCP plan's critical limit for receiving (product not surrounded by gel packs). The firm's proposed HACCP revision was inadequate as no revised plan was provided. 2. **Inadequate critical limits in HACCP plan (21 CFR 123.6(c)(3)):** The HACCP plan listed a critical limit of "(b)(4)" at receiving, but thawed gel packs were observed, and the product was still accepted. The proposed revision was inadequate without a copy of the revised plan. 3. **Missing critical control point in HACCP plan (21 CFR 1