FDA WARNING_LETTER - Masa NY, LLC - June 22, 2017

The FDA issued a Warning Letter to Masa NY, LLC following a June 22, 2017, inspection of their seafood importer establishment. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, specifically 21 CFR Part 123. Masa NY, LLC failed to comply with 21 CFR 123.12(a)(2)(ii) by not performing an affirmative step to ensure that imported fresh trevally and fresh Katsuwonus pelamis (Katsuo) from (b)(4) were processed under conditions compliant with the HACCP regulation. This deficiency renders the imported products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA requires a written response within fifteen working days, detailing specific corrective actions, including corrected HACCP and importer verification records, and documentation of affirmative steps. Failure to address these violations may lead to refusal of admission, detention without physical examination, product seizure, injunctions, and re-inspection fees under Section 743 of the Act. The firm is responsible for ensuring full compliance to prevent further violations.