FDA WARNING_LETTER - Simplydelicious - December 09, 2009

This Warning Letter, Ref. #: DEN-10-09 WL, dated January 19, 2011, was issued to Simplydelicious LLC dba Bobo's Oat Cakes, Boulder, Colorado, following an FDA inspection from November 30 to December 9, 2009. The inspection revealed serious deviations from Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 110), rendering ingredients and finished products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 342(a)(4)].

Significant violations include: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Live rodents, numerous rodent excreta pellets, and urine stains were observed in production and warehouse areas. A hole with nesting material and rodent excreta was found. Gaps under doors were also noted. This is a recurring issue from previous inspections. 2. **Improper Equipment Storage (21 CFR 110.20(a)(1)):** Accumulated unused equipment was observed outside the building. 3. **Non-Food Grade Equipment (21 CFR 110.40(a)):** An employee used a construction-type cordless drill with a chipped, painted, non-food grade metal mixing paddle. A