FDA Inspection 772646 — AAP Implantate Ag
The FDA completed an inspection of AAP Implantate Ag on March 15, 2012 in Berlin. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |