FDA WARNING_LETTER - Thanh Son Tofu Inc - April 16, 2010

On October 6, 2010, the FDA issued a Warning Letter to Thanh Son Tofu, Inc. following an inspection on April 15 & 16, 2010, which revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The FDA determined that the company's products, including soybean drink, fried tofu, soybean cake, and soybean pudding, were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Temperature Control (21 CFR 110.80(b)(3)):** Perishable products were not refrigerated or held at appropriate temperatures during holding and transport, and were displayed on unrefrigerated racks for extended periods. The company's response regarding time logs was deemed inadequate. 2. **Equipment Cleaning and Sanitizing (21 CFR 110.80(b)(1)):** Numerous pieces of equipment (soy beverage holding tank, filling plumbing, piping, separation screens, holding tank for separated liquid, metal trays, plastic totes, soybean hopper, cake molds, basket-like containers) were visibly soiled with food residues despite Clean-In-Place (CIP) or manual cleaning procedures. The company's response on employee training lacked sufficient detail. 3. **Protection Against Contamination