Empacadora Bilbo S.A. DBA Bilbosa – FDA Warning Letter, Jul 28, 2023

On February 9, 2024, the FDA issued a Warning Letter to Empacadora Bilbo S.A. DBA Bilbosa following an inspection on July 27-28, 2023, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA acknowledged the firm's responses from August 11 and October 13, 2023, but found continued serious concerns.

The primary violation is that the firm's frozen, raw, histamine-forming fish are adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as they were prepared, packed, or held under injurious conditions.

Specific deviations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for frozen raw fish, dated August 8, 2023, lacks a critical control point at the "(b)(4)" step to control scombrotoxin (histamine) formation, particularly for refrigerated storage. The FDA recommends maintaining fish at 40°F (4.4°C) or below, or continuously surrounded by ice. 2. **Inadequate Monitoring Procedures (21 CFR 123.6(c