FDA WARNING_LETTER - Los Genuinos, Inc. - January 25, 2011

The FDA inspected Los Genuinos, Inc.'s food manufacturing facility from January 11-25, 2011, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Food products were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

CGMP violations included: 1. **Pest Exclusion (21 CFR 110.35(c)):** Observed flies on food contact surfaces, ants on mixing tables, spider webs, and an industrial fan blowing filth from the floor onto unpackaged products. 2. **Pest Protection (21 CFR 110.20(b)(7)):** An open screened gate allowed birds and flies into the production area, and ill-fitting window screens had gaps. 3. **Sanitary Maintenance (21 CFR 110.35(a)):** Missing ceiling sections, peeling paint, water filtration issues with water-damaged packaging, and accumulation of bird excrement, feathers, and dust on windows and screens. 4. **Light Fixture Protection (21 CFR 110.20(b)(5)):** Light fixtures lacked protective coverings to prevent glass breakage contamination. 5. **Hand-Washing Facilities (21 CFR 110