# FDA WARNING_LETTER - Duong Ha Processing Trading Seafood Company Limited - July 09, 2024

Source: https://www.keypedia.com/records/warning_letter/duong-ha-processing-trading-seafood-company-limited/f9f2d5db-0cfd-48bd-a895-c1e711482eb6

> FDA WARNING_LETTER for Duong Ha Processing Trading Seafood Company Limited on July 09, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Duong Ha Processing Trading Seafood Company Limited
- Inspection Date: 2024-07-09
- Product Type: Food
- Office Name: Human Foods Program
- Summary: 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

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Company: https://www.keypedia.com/companies/duong-ha-processing-trading-seafood-company-limited/f31c4bd5-75ef-4f6b-98af-5a7a56f4e90a

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324