FDA WARNING_LETTER - Massimo's Dallas, Inc. - June 13, 2012

On June 5-13, 2012, the FDA inspected Massimo's Dallas, Inc., a food manufacturing firm, and found serious violations of Current Good Manufacturing Practice Regulations (21 CFR Part 110). These violations render the ready-to-eat baked food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Hygienic Practices (21 CFR 110.10(b)(1) & (3)):** Employees failed to wash and sanitize hands before handling ready-to-eat products and after handling trash. Employees also lacked protective outer garments and hair restraints in production areas. 2. **Building Maintenance (21 CFR 110.35(a)):** Peeling/flaking paint was observed on ceilings directly over uncovered food and food contact surfaces. Rainwater leaked in multiple areas where products were held or processed. 3. **Extraneous Material Control (21 CFR 110.80(b)(8)):** Chipped knives and scoops were used, and a roll divider was missing metal pins, posing a risk of metal inclusion in food. 4. **Production Procedures (21 CFR 110.80):** Uncovered ready-to-eat products contacted