FDA Inspection 770796 — Thompson Ocular Prosthetics, Inc
The FDA completed an inspection of Thompson Ocular Prosthetics, Inc on Mar 6, 2012 in San Antonio, 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
- Mar 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |