FDA WARNING_LETTER - Sri Lankan Delight, Inc. - January 29, 2013

On March 19, 2013, the FDA issued a Warning Letter to Sri Lankan Delight, Inc. following an inspection from January 9-29, 2013. The inspection revealed serious violations of the Hazard Analysis and Critical Control Point (HACCP) regulation for fish and fishery products (21 CFR Part 123), specifically concerning imported products under 21 CFR Part 123.12.

The FDA found that Sri Lankan Delight, Inc. failed to implement written verification procedures, product specifications, and affirmative steps to ensure imported fish and fishery products comply with Seafood HACCP regulations, as required by 21 CFR Part 123.12(a)(2). This deficiency applied to various products imported from two specific manufacturers, including Maldive Fish Sambol, Wet Seeni Sambol, Katta Sambol, and several dried fish products. A letter provided by one manufacturer stating their facility was "governed by an HACCP Manual" was deemed insufficient to satisfy the affirmative steps requirement.

Consequently, the listed products were 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. The FDA warned of potential actions, including refusal of admission, detention without physical examination, seizure,