946072
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |