FDA WARNING_LETTER - Celtrock Holdings Limited

The FDA issued a Warning Letter to Celtrock Holdings Limited, parent company of Sea Quest (Fiji) Limited, following a review of their seafood processing documents, which revealed serious deviations from U.S. seafood HACCP regulations (21 CFR 123). The scombroid species of fish processed by Celtrock/Sea Quest are deemed adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2))**: The HACCP plan lacks critical control points (CCPs) for: * Receiving fish directly from harvest vessels (primary processor activities) to control scombrotoxin formation, as internal temperatures at off-loading are not adequately monitored. * Processing periods with unrefrigerated handling (e.g., loading, transport, grading, butchering), failing to control time and temperature exposures. * Storage/holding of unrefrigerated fish, with an unclear and ineffective "CCP 2" that relies on unreliable chilling methods (ice packs) and inadequate temperature monitoring. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4))**: Monitoring procedures at the "Receipt of FP at Processing Plant (CCP1)" are inadequate. Harvest vessel records do not reliably assure fish were iced within six hours of death, especially for fish