Duong Ha Processing Trading Seafood Company Limited – FDA Warning Letter, Jul 9, 2024

On November 26, 2024, the FDA issued a Warning Letter to Ward 12, 1705, 30/4 Street, Vung Tau, Ba Ria-Vung Tau Province, Vietnam, following an inspection from July 8-9, 2024. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen, raw, vacuum-packaged, scombrotoxin-forming fish adulterated under 21 U.S.C. § 342(a)(4).

Despite the firm's responses on July 19 and September 16, 2024, the FDA found continued serious concerns with their HACCP program for "Seafish, Frozen Fillet." Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The plan lacks a critical control point for unrefrigerated processing to control scombrotoxin (histamine) formation. 2. **Missing/Inadequate Critical Limits (21 CFR 123.6(c)(3)):** No critical limit is listed for internal fish temperatures at off-loading to control histamine formation. The critical limit for *Clostridium botulinum* control is