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FDA Warns Vietnam Fish Processor for Inadequate Plan to Control Histamines

The Food and Drug Administration found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation in Vietnamese fish processor Hai Nam Co., Ltd.’s response to an earlier letter, it said in a warning letter dated June 18. FDA said it found Hai Nam’s HACCP plan to control histamine formation in mahi-mahi inadequate because: (1) it does not contain adequate critical limits; (2) its corrective action plans are not appropriate; (3) the plan does not list the food safety hazards of undeclared allergens; and (4) it does not list the critical control points.

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FDA said Hai Nam should respond in writing within 15 working days from receipt of the warning letter, or FDA may take further action, such as refusal of admission of New Life’s imported fish or fishery products, including placing them on detention without physical examination (DWPE).

(FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts.)