260 Commercial Investments Inc. – FDA Warning Letter, Jul 11, 2013

The FDA inspected Browne Trading Company's seafood processing facility from May 23 to July 11, 2013, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders the firm's ready-to-eat smoked seafood products adulterated under Section 402(a)(4) of the Act. Deficiencies include HACCP plans failing to identify undeclared allergens as a food safety hazard (21 CFR 123.6(a) and (c)(1)). Critical limits for controlling pathogen growth, including Clostridium botulinum, were inadequate in HACCP plans for receiving, chilled storage, and brining (21 CFR 123.6(c)(3)). The firm also failed to implement required record-keeping for brine ratios (21 CFR 123.6(b)) and did not consistently follow monitoring procedures for cooling media and product temperatures at receiving (21 CFR 123.6(b) and (c)(4)). Corrective action plans were inappropriate, often relying on microbiological testing or failing to address root causes of deviations (21 CFR 123.7(b)). Additionally, the firm did not take adequate corrective actions when verification testing revealed critical limit failures (21 CFR 123.8(b)). Sanitation conditions and practices were not monitored with sufficient frequency, evidenced by dirty equipment and rusted floors (21 CFR 123.11(b) and 21 CFR Part 110). Lastly, processing information was not entered on records at the time of observation (21 CFR 123.9(a)). The FDA requires a written response within 15 working days detailing corrective actions, including revised HACCP plans, to prevent further enforcement actions like product seizure, injunction, and re-inspection fees.