Tofu Yu, LLC – FDA Warning Letter, Oct 25, 2016

On December 22, 2016, the FDA issued a Warning Letter to Tofu Yu, LLC, following an inspection from October 11-25, 2016. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their ready-to-eat tofu and tofu products, including tofu veggie wraps, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Improper Maintenance of Equipment and Utensils (21 CFR 110.80(b)(1)):** Investigators observed discolored and dirty equipment, including a coagulant pitcher, tofu shape-maker, tofu press plate, rice tortilla making equipment, and a wooden cutting board, all with dried residues. 2. **Contamination from Production Procedures (21 CFR 110.80):** Uncovered tofu products in a walk-in cooler were stored directly beneath a dripping condensate from the cooler fan unit. 3. **Pest Control Deficiencies (21 CFR 110.35(c)):** Approximately 30 live flying insects were observed in the tofu manufacturing area, perching on walls, a hose above equipment, and contacting processing equipment, including a soybean soaking barrel and conveyor belt. Similar issues were noted in previous