FDA WARNING_LETTER - Bernhard's Bakery, Inc. - August 21, 2008

On November 19, 2008, the FDA issued a Warning Letter to Bernhard's Bakery Inc. following an inspection conducted on August 12-14 and 19-21, 2008. The inspection revealed serious deviations from Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 110), rendering ingredients and finished products adulterated under Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Raw Material Contamination (21 CFR 110.80(a)(1)):** Live and dead insects were found in raw materials (doughnut cake mix, devils food cake mix, chocolate cake mix, flour, sugar) and a finished doughnut. 2. **Equipment and Food Contact Surface Sanitation (21 CFR 110.80(b)(1), 110.80(b)(2), 110.35(d)):** Insects were observed in clean baking tray containers, on equipment (sheeter, dough divider, ingredient weighing station), and in a mixing bowl. Rodent excreta pellets (REPs) were found near the pan washing area, under a sandwich preparation table, and in a restroom/storage room. A dead mouse was also found. 3. **Facility Sanitation and