FDA WARNING_LETTER - Maharaja Foods Importers Inc. - April 15, 2014

On April 11-15, 2014, the FDA inspected Maharaja Foods Importers Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12 for imported fish and fishery products. The firm's glass-packed pickled tuna in oil, marketed as shelf-stable, was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to insanitary conditions.

A significant violation was the firm's failure to implement an affirmative step to ensure imported fish and fishery products are processed according to seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii), for glass-packed pickled tuna in oil from (b)(4). Additionally, an FDA sample of this product was found to be an acidified food subject to 21 CFR Parts 108 and 114. The foreign manufacturer failed to register and file a scheduled process for this product, as required by 21 CFR 108.25. Consequently, the product was refused admission on (b)(4) under Section 402(a)(4) of the Act