FDA WARNING_LETTER - Tri-County Food Service & Distribution Inc - June 30, 2010

An FDA inspection of Tri-County Food Service & Distribution, Inc. on June 8,9,17,30, 2010, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Consequently, the firm's tuna salad and fish (Cod) sandwiches are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key HACCP violations include the lack of separate HACCP plans for distinct product lines, failure to list all reasonably likely food safety hazards (e.g., scombrotoxin, pathogen survival), absence of critical control points for pathogen growth and histamine formation, and inadequate record-keeping for critical control points. Additionally, corrective action plans were found to be inappropriate, and sanitation monitoring was insufficient, with observed cross-contamination risks, improper cleaning, and poor employee hygiene. The inspection also identified misbranding issues under Section 403 of the Act (21 CFR Part 101) for Fish Hoagie, Tuna Salad Croissant, and Tuna & Noodles products, primarily due to undeclared ingredients/sub-ingredients, missing manufacturer information, and illegible or poorly presented mandatory label information. The firm must respond in writing within fifteen working days, detailing specific corrective actions, including supporting documentation, to avoid further regulatory action such as product seizure or injunction.