FDA WARNING_LETTER - Hong Lee Trading Inc. - January 17, 2014

On January 15-17, 2014, the FDA inspected Hong Lee Trading Inc., a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm failed to implement an affirmative step to ensure imported dried anchovy fish, manufactured by (b)(4) in (b)(4), was processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii).

A sample of this dried anchovy, imported under entry number (b)(4) on September 30, 2013, was found to contain (b)(4) by FDA laboratory analysis, rendering it adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). The entry was refused admission on (b)(4). The FDA stated that the dried anchovy was also adulterated under Section 402(a)(4) of the Act because it was prepared, packed, or held under insanitary conditions.

The FDA warned that failure to correct these violations could result in refusal of admission for imported products, detention without physical examination, seizure, and/or injunction. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification