FDA WARNING_LETTER - Weyand Fisheries, Inc. - April 23, 2013

On August 27, 2013, the FDA issued a Warning Letter to Weyand Fisheries, Inc. following an inspection from April 11-23, 2013, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and the company's May 7, 2013, response, including revised HACCP plans, was deemed inadequate, specifically for observation 2-a.

The FDA determined that the company's pasteurized crab meat products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under unsanitary conditions.

Significant violations included: 1. **Inadequate Corrective Actions (21 CFR 123.7(b)):** The HACCP plan for Pasteurized Crab Meat listed inadequate corrective actions for deviations from critical limits at the "Receiving" and "Cold Storage" critical control points, failing to control pathogens like *Clostridium botulinum*. For example, the corrective action for "Cold Storage" was inconsistent with the 40°F critical limit and did not address temperatures exceeding a specific limit. The FDA recommended chilling, evaluating, or destroying affected product. 2. **Missing Critical Limits (21