FDA Inspection 709723 — IT Dr. Gambert Gmbh
The FDA completed an inspection of IT Dr. Gambert Gmbh on Jan 27, 2011 in Wismar. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 27, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wismar (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |