wendell corporation – FDA Warning Letter, Jun 21, 2012

On August 29, 2012, the FDA issued a Warning Letter to Wendell Corporation following an inspection of their bakery in Honolulu, Hawaii, from June 19-21, 2012. 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 included: 1. **Pest Control (21 CFR 110.35(c), 110.20(b)(7)):** Flies were observed landing on processing surfaces and in-process dough. The back doors in processing rooms were left open, lacking adequate pest protection. 2. **Hygienic Practices (21 CFR 110.10(b)(3), 110.10(b)(5)):** An employee handled dough with bare hands after wiping their nose and coughing without washing. Employees were seen eating and drinking in production areas. 3. **Equipment Maintenance and Cleanliness (21 CFR 110.40(a), 110.40(c), 110.35(b)(1)):** Equipment (wooden tables, dough sheeting machine, bread slicing machine, baking sheets, mixer table