FDA Inspection
Metro Optics of Austin, Inc.Metro Optics of Austin, Inc. – FDA Inspection, Oct 15, 2026
Record Details
This FDA Inspection record concerns Metro Optics of Austin, Inc., with an inspection on October 15, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Metro Optics of Austin, Inc.
- Inspection Date
- October 15, 2026
- Product Type
- Devices
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ID · d7421487-164b-478b-b244-89f638f2b7ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1342276
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
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Other FDA inspections of Metro Optics of Austin, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2024 | Not classified | Dallas District Office | |
| September 19, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 26, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Metro Optics of Austin, Inc.
- FDA Inspection 1232494 - 2024-02-22
- FDA Inspection 1068595 - 2018-09-19
- FDA Inspection 962762 - 2016-02-26
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