FDA WARNING_LETTER - Pulmuone Foods USA, Inc. - September 30, 2013

On September 19 and 30, 2013, the FDA inspected Pulmuone Foods USA, Inc.'s seafood processing facility in Gilroy, CA, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's refrigerated lobster ravioli and seafood lasagna in reduced oxygen packaging are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The firm's October 17, 2013, response to the FDA 483 was inadequate as revised HACCP plans were not provided.

Significant violations include the failure to: 1) Conduct a proper hazard analysis and list all reasonably likely food safety hazards, such as pathogens (e.g., Listeria monocytogenes from time/temperature abuse) and undeclared allergens (shellfish, wheat, milk, eggs), in HACCP plans for lobster ravioli and seafood lasagna, as required by 21 CFR 123.6(a) and (c)(1). 2) List critical control points in HACCP plans for refrigerated lobster ravioli and seafood lasagna to control Clostridium botulinum growth and toxin formation during the thawing of frozen lobster meat in vacuum-sealed packages and during finished product cold storage, violating 21 CFR 123.6(a) and (c)(2). 3) List a critical control point to control Clostridium botulinum growth and toxin formation in refrigerated reduced oxygen packaged products, specifically regarding adequate water activity, water phase salt, or pH.

The FDA may take further action, including product seizure or injunction, and assess re-inspection fees. The firm must respond in writing within fifteen working days, outlining specific corrections, including revised HACCP plans and monitoring records, to demonstrate compliance with the Act, seafood HACCP (21 CFR Part 123), and Current Good Manufacturing Practice (21 CFR Part 110).