FDA WARNING_LETTER - Lee K of NY Inc. - April 22, 2013

An FDA inspection of LEE K OF NY, INC.'s seafood processing facility in April 2013 revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, several of the firm's products, including grilled mackerel and fried whole flounder, are deemed adulterated. Key HACCP deficiencies included failure to conduct adequate hazard analyses for scombrotoxin, failure to list critical control points for pathogen growth, inadequate critical limits (e.g., lack of time for cooking), insufficient monitoring procedures and frequencies, and failure to implement monitoring and record-keeping systems. Additionally, the firm's corrective actions were found to be inappropriate. Sanitation violations under 21 CFR 123.11(b) and (c) included inadequate monitoring of sanitation conditions, evidenced by unclean food contact surfaces, cross-contamination, lack of hot water for handwashing, unprotected food packaging, and a significant pest infestation (live and deceased mice). The firm also failed to maintain sanitation control records. The FDA requires a written response within fifteen working days detailing specific corrections and supporting documentation. Failure to promptly correct these violations may result in further regulatory action, including product seizure, injunction, and assessment of reinspection fees.