FDA Inspection 665629 — CeramTec GmbH, Medical Products Division
The FDA completed an inspection of CeramTec GmbH, Medical Products Division on Apr 29, 2010 in Marktredwitz. 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
- Apr 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Marktredwitz (Germany)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 2403 | 21 CFR 820.25(a) | Sufficient personnel |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |