The Cake Box, Inc. – FDA Warning Letter, Sep 28, 2011

On December 14, 2011, the FDA issued a Warning Letter to The Cake Box, Inc. following an inspection from September 20-28, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Pest Control (21 CFR 110.35(c)):** Evidence of pests was found, including a dead rat, 25-30 rodent pellets, and rodent nesting material near raw ingredients and finished products, and moths in the production room, some on cloths covering dough. 2. **Equipment and Utensil Sanitation (21 CFR 110.80(b)(1), 110.35(d)):** Roller racks, baking pans, and cotton cloths had old product residue. An employee was observed scraping a dead moth off a table with a dough scraper. 3. **Hand Washing (21 CFR 110.10(b)(3)):** Employees handled raw dough without washing hands at the start of work. One employee smashed a moth with bare hands, wiped it on the floor, and immediately resumed dough forming without washing