821991
Glasir Medical, LP — FEI 3007789227
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |