FDA WARNING_LETTER - Cau Tre Export Goods Processing Joint Stock Company - April 15, 2014

On November 24, 2014, the FDA issued a Warning Letter to Cau Tre Export Goods Processing Joint, a seafood processing facility in Ho Chi Minh City, Vietnam, following an April 14-15, 2014 inspection. The letter addresses continuing serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp hacao/shaomai, and frozen shrimp wonton soup products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include inadequate critical limits in HACCP plans for pathogen control during cooking, specifically lacking specific values for cooking temperature, time, batch size, and portion size. Additionally, critical limits for sulfite control at the "Receiving Catch Shrimp" critical control point were deemed insufficient, as they did not account for post-capture sulfite addition. Monitoring procedures and frequencies at the cooking critical control point were also found inadequate, with the FDA recommending continuous temperature recording and visual checks.

The FDA requires a written response within fifteen working days, outlining specific corrective actions, including a revised HACCP plan and five consecutive days of completed monitoring records. Failure to comply may result in refusal of admission of imported products, including detention without physical examination (DWPE) under Import Alert #16-120, and assessment of