FDA WARNING_LETTER - M & B Sea Products Inc - August 04, 2014

The FDA inspected M & B Sea Products, Inc. in New Bedford, MA, from July 28 to August 4, 2014, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's refrigerated, reduced oxygen packaged raw scallops are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to have a HACCP plan with adequate critical limits to control Clostridium botulinum toxin formation for reduced oxygen packaged scallops, as required by 21 CFR 123.6(c)(3). The firm also failed to implement monitoring procedures and frequencies listed in its HACCP plan, specifically for visual examination, and did not maintain monitoring records, violating 21 CFR 123.6(b) and (c)(4). Furthermore, the firm lacks an individual trained or qualified in seafood HACCP to perform critical functions like plan development, reassessment, and modification, as mandated by 21 CFR 123.10. The firm's August 18, 2014, response was inadequate, lacking amended HACCP plans, evidence of implemented corrective actions, proposed timetables, or a plan for interim HACCP review. The FDA requires a written response within fifteen working days outlining specific corrections and documentation. Failure to comply may result in product seizure, injunction, and re-inspection fees.