FDA WARNING_LETTER - H. A. R. Maspeth Corp. - May 02, 2014

On April 24 and May 2, 2014, the FDA inspected H.A. R. Maspeth Corp., a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As an importer, the firm must ensure imported fish and fishery products comply with 21 CFR Part 123.

The significant violation identified was the firm's failure to implement an affirmative step to ensure imported dried squid slices from (b)(4) were processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). An FDA sample of these dried squid slices, imported under entry number (b)(4), tested positive for Salmonella and was refused admission on September 23, 2013. This renders the dried squid adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm's May 6, 2014, written response to the FDA 483, Inspectional Observations, was reviewed but found insufficient due to a lack of documentation verifying the promised corrective actions. Failure to promptly correct these violations may result in further action, including refusal of admission of imported products, "detention without physical examination," product seizure, and/or injunctions. The