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

Source: https://www.keypedia.com/records/warning_letter/massimos-dallas-inc/4b113c52-b4e4-43df-99dc-3f57eafaccd2

> FDA WARNING_LETTER for Massimo's Dallas, Inc. on June 13, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Massimo's Dallas, Inc.
- Inspection Date: 2012-06-13
- Product Type: Food
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)
- [Mohammed F. Damrah](https://www.keypedia.com/people/mohammed-f-damrah/fc3098fa-203a-41ba-a2b7-7028456108af)

Company: https://www.keypedia.com/companies/massimos-dallas-inc/89bb1bae-e671-460c-ab7a-8dcd295aed8a

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9