Koryeo International Corp. – FDA Warning Letter, Aug 6, 2014

The FDA inspected Koryeo International Corp., a seafood importer in Brooklyn, NY, on August 1 and 6, 2014, 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 its imported frozen breaded raw oysters were processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This deficiency means there is no evidence that the imported products comply with FDA requirements, rendering them adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Koryeo International Corp. must respond in writing within fifteen working days, outlining specific corrective actions, including corrected HACCP and importer verification records, and documentation of affirmative steps. Failure to correct these violations could lead to refusal of admission for imported products, detention without physical examination, product seizure, injunctions, and the assessment of re-inspection fees.