FDA Inspection 1342276 — Metro Optics Of Austin, Inc.
The FDA completed an inspection of Metro Optics Of Austin, Inc. on Oct 15, 2026 in Pflugerville, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 15, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pflugerville, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |