FDA WARNING_LETTER - T. Ho Foods, Inc. - June 27, 2013

On June 26-27, 2013, the FDA and Tennessee Department of Agriculture inspected T-Ho Foods in Powell, Tennessee, and found significant deviations from seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practices (CGMP) (21 CFR 110). These violations render all seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct hazard analyses for crab cakes and crab rangoon (21 CFR 123.6(a)). 2. Failure to establish written HACCP plans for crab cakes and crab rangoon to control pathogen growth and allergens/additives (21 CFR 123.6(b)). 3. Failure to maintain sanitation control records for water safety, cross-contamination prevention, handwashing facilities, food protection, chemical storage, employee health, and pest exclusion (21 CFR 123.11(c)). 4. Failure to exclude pests, with excessive rodent excreta and house flies observed (21 CFR 110.35(c)). 5. Failure to maintain sanitary buildings and fixtures, including mold on walls (21 CFR 110.35(a)). 6. Failure to maintain facilities