FDA WARNING_LETTER - T. Ho Foods, Inc. - June 03, 2015

On June 1-3, 2015, the FDA inspected T-Ho Foods' seafood processing facility in Powell, Tennessee, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (GMP) regulations (21 CFR 110). These violations render the firm's seafood products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **HACCP Deficiencies:** Failure to fully document corrective actions for critical limit deviations (e.g., temperature for a product on Dec 1, 2014), implement stated monitoring frequencies (e.g., checking equipment for chips/damages), conduct a proper hazard analysis for undeclared allergens at the labeling CCP (a repeat observation), and sign/date HACCP plans upon modification. - **GMP Violations:** Evidence of extensive rodent activity (at least 67 apparent rodent excreta pellets) in multiple areas, including food ingredient and packaging material storage (a repeat observation). Failure to properly store equipment, remove litter/waste, and cut weeds/grass around the facility. Improper operation of fans with dust/debris blowing onto exposed food. Uncovered bulk ketchup in the production room. Leaking freezer wall causing pooled water and ice condensation drip on food products. Employees blowing into disposable gloves before handling food. Use of a broken wire whisk. Rusty and