771915
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Quinlan, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |