FDA WARNING_LETTER - Kuang Pei San Food Products Public Col, PLC.

The FDA issued a Warning Letter to Kuang Pei San Food Products Public Col, PLC., following an evaluation of their revised HACCP plans for mackerels/sardines, catfish/clarias, and baby clams. This letter, a follow-up to a February 2012 communication and inspection, found the firm's March 2012 response insufficient. The company continues to have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering their products adulterated under Section 402(a)(4) of the Act. Key violations include the failure to conduct a proper hazard analysis and list critical control points for mackerels/sardines to control histamine (21 CFR 123.6(a) and (c)(2)). Monitoring procedures and frequencies for histamine at receiving for mackerels/sardines were inadequate (21 CFR 123.6(c)(4)). Critical limits were inappropriate, lacking sensory evaluation limits for mackerels/sardines and an incomplete list of aquaculture drugs for catfish/clarias (21 CFR 123.6(c)(3)). Corrective actions for histamine control were also deemed inappropriate (21 CFR 123.7(b)). Additionally, the firm used undefined abbreviations and listed an inappropriate critical limit for allergen labeling. The FDA requires a written response within 15 working days, detailing specific corrective actions with supporting documentation. Failure to adequately respond may result in further regulatory action, including refusal of admission of imported seafood products into the U.S. and placement on Detention Without Physical Examination (DWPE) under Section 801(a) of the Act, potentially through Import Alert #16-120. The firm must comply with 21 CFR Part 123 and 21 CFR Part 110.