Reunipeche SAS – FDA Warning Letter, Jul 4, 2024

On December 26, 2024, the FDA issued a Warning Letter to Mr. Hubert Chenede following an inspection of their seafood processing facility in Le Port, La Reunion, France, on July 3 and 4, 2024. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their whole fresh fish adulterated under 21 U.S.C. § 342(a)(4).

Despite the firm's email responses on July 19, September 16, and September 24, 2024, the FDA found the HACCP program still had serious concerns. Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The revised HACCP plan for "(b)(4)" dated July 17, 2024, failed to list pathogen growth and toxin formation for products intended for raw consumption. While other documents listed hazards like Listeria, parasites, histamine, and allergens, these were not included in the HACCP plan itself. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * The critical limit of "(b)(4)" at CCP1 "(b)(4)" was