FDA WARNING_LETTER - Bonaterra Products, Inc. - January 14, 2011

On April 18, 2011, the FDA issued a Warning Letter to Bonaterra Products, Inc. following an inspection of their food storage facility in Maywood, CA, from January 4-14, 2011. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice regulations (21 CFR Part 110), rendering the stored spices and chilies adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Live rodents, rodent excreta on food products and storage areas, and numerous dead insect particles on over 100 bags of spices and chilies were observed. No documentation of pest control measures was provided. 2. **Unsanitary Facility Maintenance (21 CFR 110.35(a)):** Food products were on the floor, food debris and rodent excreta were widespread, and over ten wet boxes of Chile Guajillo (contaminated with mold per FDA analysis) were found due to apparent roof leaks. Broken windows and a hole with mold-like substance in the restroom ceiling were also noted. No documentation of corrective steps was provided. 3. **Inadequate Pest Protection (21 CFR 110.20(b)(