FDA WARNING_LETTER - FIRST LOTUS INC - April 23, 2015

On June 17, 2015, the FDA issued a Warning Letter to First Lotus, Inc. following an inspection from April 21-23, 2015. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for their seafood importer establishment.

Specifically, First Lotus, Inc. failed to implement written verification procedures, product specifications, and an affirmative step to ensure imported fish comply with the Seafood HACCP regulation. This deficiency was noted for Dried Fish Maw (Cape Conger) and Dried Stock Fish. As a result, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), indicating they were prepared, packed, or held under insanitary conditions that could render them injurious to health.

The FDA warned that failure to promptly correct these violations could lead to further action, including refusal of admission of imported products under Section 801(a) of the Act (21 U.S.C. § 381(a)), placing products on "detention without physical examination," seizure of products, and/or injunctions. First Lotus, Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions and providing supporting documentation such as