FDA WARNING_LETTER - True World Foods Chicago LLC - May 06, 2011

An FDA inspection of True World Foods Chicago LLC's seafood processing facility from March 8 to May 6, 2011, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). These deficiencies render the firm's refrigerated and raw, Ready-To-Eat (RTE) seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards (e.g., parasites, undeclared allergens, Clostridium botulinum) in HACCP plans, as required by 21 CFR 123.6(a) and (c)(1). The firm also failed to establish adequate critical limits in its HACCP plans, such as proper receiving temperatures and internal temperature monitoring, violating 21 CFR 123.6(c)(3). Furthermore, the company did not implement the monitoring procedures and frequencies listed in its HACCP plans (21 CFR 123.6(b) and (c)(4)), particularly for Ocean Harvested Crab. Significant GMP violations (21 CFR 123.11(b)) included inadequate monitoring of sanitation conditions, evidenced by unsafe water hoses, improper use of totes, and poor employee hygiene. Finally, the corrective actions outlined in several HACCP plans were deemed inappropriate, failing to comply with 21 CFR 123.7(b), with issues like unacceptable critical limit responses and insufficient thawing temperature monitoring. The FDA requires a written response within fifteen working days detailing specific corrective actions and supporting documentation. Failure to comply may result in product seizure or an injunction against the firm's operations.