FDA WARNING_LETTER - APIA EXPORT FISH PACKERS LTD - August 27, 2019

On January 8, 2020, the FDA issued a Warning Letter to Apia Export Fish Packers Ltd following an inspection on August 26-27, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The FDA-483, Inspectional Observations, was issued, and the company's September 10, 2019, response, including a revised HACCP plan and blank monitoring records, was deemed insufficient.

The FDA determined that the firm's fresh tuna products are adulterated under 21 U.S.C. § 342(a)(4) due to preparation, packing, or holding conditions that may render them injurious to health.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for "Chilled and Frozen Fish" failed to list chilled storage as a critical control point for scombrotoxin (histamine) formation. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** Critical limits at the receiving critical control point were insufficient to control scombrotoxin formation from harvest vessels. The FDA recommended additional critical limits for harvest vessel records or histamine testing, and clarified