Vinh Sam Enterprise – FDA Warning Letter, Sep 10, 2007

On January 29, 2008, the FDA issued a Warning Letter to Vinh Sam Enterprise following an inspection of a U.S. importer, Nu-Wave Seafood Consultants, LLC, from September 4-10, 2007. The inspection revealed that Vinh Sam Enterprise's HACCP plan for "Fresh Chilled Fish Products," including scombroid (histamine) forming species (Yellow Fin Tuna, Mahi Mahi) and natural toxin susceptible species (grouper), had serious deviations from 21 CFR Part 123, rendering their products adulterated under 21 USC § 342(a)(4).

Key violations include: 1. **Lack of Critical Limits (21 CFR 123.6(c)(3)):** * **Histamine Development (Receiving):** The HACCP plan lacked a critical limit for histamine development at the "Receiving of raw material" critical control point. For primary processing, the FDA recommended including a critical control point for receipt of fish from harvest vessels, suggesting review of harvest vessel records or histamine testing, along with sensory examination of at least 118 fish per lot. For secondary processing, the FDA recommended amending the receiving critical control point to ensure proper chilling during transit, suggesting continuous temperature monitoring records or monitoring for adequate ice/cooling media. * **Ciguatera Food Poisoning (Receiving):** The plan