FDA WARNING_LETTER - I.T. Foods Industries Co., LTD. - February 15, 2008

An FDA inspection of I.T. Foods Industries Co., Ltd. in Thailand on February 14-15, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Specifically, the firm failed to conduct a proper hazard analysis and implement a compliant HACCP plan as required by 21 CFR 123.6(a) and (c)(2). The HACCP plan for frozen steamed mackerel and frozen fresh anchovy did not identify "Receiving" as a critical control point for controlling histamine, particularly when fish are received directly from harvest vessels. This deficiency renders the firm's products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. FDA recommends implementing controls such as monitoring internal fish temperatures, obtaining harvest vessel records or conducting histamine testing, and performing sensory examinations for decomposition. The firm must respond in writing within thirty working days, detailing corrective actions, including revised HACCP plans and five days of monitoring records. Failure to adequately respond may result in refusal of admission of imported products into the U.S., including Detention Without Physical Examination (DWPE).