# FDA 483 - METRO OPTICS, INC - March 17, 2025

Source: https://www.globalkeysolutions.net/records/483/metro-optics-inc/06285c0e-78ec-4ec7-a71a-55b3920d30b1

> FDA 483 for METRO OPTICS, INC on March 17, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: METRO OPTICS, INC
- Inspection Date: 2025-03-17
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of METRO OPTICS, INC, a manufacturer in Dallas, TX, revealed significant deficiencies in their document control procedures. The firm failed to adequately establish and follow processes for documenting and implementing changes, ensuring document suitability, and providing required audit records. These issues indicate a breakdown in their quality system for managing critical operational documents.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Yuliana Hernandez-Magana](https://www.globalkeysolutions.net/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.globalkeysolutions.net/companies/metro-optics-inc/77f44d07-f31f-42d2-b6b5-babe145ea848

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