FDA WARNING_LETTER - Rey de los Camarones S. A. - August 30, 2024

On December 23, 2024, the FDA issued a Warning Letter to Mr. Jianwei Rong, owner of a seafood processing facility in Managua, Nicaragua, following a Foreign Remote Regulatory Assessment (FRRA) conducted from August 26-30, 2024. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically rendering the firm's dried and salted sea cucumber products adulterated under 21 U.S.C. § 342(a)(4). No response to the initial observations was received.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for dried sea cucumber lacks a critical control point (CCP) for drying to control biological pathogen growth, including *Staphylococcus aureus*. The firm relies on sensory examination and does not perform water activity testing. There is no scientific validation for current drying procedures (drying room at (b)(4)°C for (b)(4) days or sun drying for (b)(4) days). The FDA recommends a CCP at the drying step to achieve a water activity of (b)(4) or below, supported by a scientific validation study, and implementation of time/temperature controls (below 10°C or limited exposure