FDA WARNING_LETTER - Sea Express Inc - December 15, 2010

The FDA inspected Sea Express Inc.'s seafood processing facility in Maspeth, NY, from December 9-15, 2010, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These failures render the firm's seafood products adulterated. Key violations include the absence of a HACCP plan for refrigerated raw Flounder to control parasite hazards, and an inadequate HACCP plan for "Histamine/C bot" with insufficient critical limits and inconsistent temperature settings. The firm also failed to implement its record-keeping system, lacking monitoring records for histamine control at the receiving critical control point. Furthermore, sanitation conditions were not adequately monitored, leading to observed cross-contamination risks, such as spraying a dirty floor hose near ready-to-eat tuna and unclean plastic curtains contacting product. Issues with water safety included a hose without adequate backflow prevention, with its nozzle sitting in stagnant floor water. The firm's December 18, 2010, response was deemed inadequate for not confirming corrections or providing specific timelines. Sea Express Inc. must promptly correct all violations, submit a written response within 15 working days detailing corrective actions, including revised HACCP plans and monitoring records, and explain how cumulative time/temperature exposures are measured. Failure to comply may result in product seizure or injunction.