Fong Kee Tofu Company, Inc. – FDA Warning Letter, Dec 21, 2011

On December 13-21, 2011, the FDA inspected Fong Kee Tofu Company, Inc., identifying serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) and misbranding issues (21 CFR Part 101). These violations render products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions, and misbranded under Section 403.

Key violations include: 1. **Pest Control (21 CFR 110.35(c)):** Pigeons and numerous live flies/gnats were observed in the manufacturing plant near raw materials and ready-to-eat product areas. 2. **Plant Construction and Maintenance (21 CFR 110.20(b)(4)):** Production area floors had missing tiles, uneven surfaces with food debris, and walk-in cooler walls had thick black residue, cracks, and crumbles. 3. **Employee Hygiene (21 CFR 110.10(b)(3)):** Employees handled ready-to-eat tofu with the same gloves after operating forklifts/pallet jacks, and with ungloved hands without washing. 4. **Plumbing (21 CFR 110.37(b)):** The only production area handwashing sink lacked a drain pipe