FDA WARNING_LETTER - Biofournil Of America Inc. - March 14, 2013

The FDA conducted an inspection of Boulangerie Nantaise, located at 2507 4th Ave, Seattle, Washington, from February 19 to March 14, 2013. The inspection revealed serious violations of Current Good Manufacturing Practice regulations (21 CFR Part 110), rendering 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 Exclusion Failure (21 CFR 110.35(c)):** Presence of dead and live insects (including red flour beetles confirmed by lab analysis) and extensive mouse excreta pellets and urine stains in production, baking, and storage areas, including on equipment and near ingredients. 2. **Improper Equipment Maintenance (21 CFR 110.80(b)(7)):** A dough hook in wastewater, cracked/gouged wooden utensils, a taped mixer casing, and a plastic bin with dough on the floor. 3. **Unsanitary Utensils (21 CFR 110.40(a)):** Repeated use of soiled plastic bags for dough and soiled cardboard cutouts for croissant dough. 4. **Improper Toxic Compound Storage (21 CFR 110.35(b)(2)):** Acetone near parchment paper and dough