FDA Inspection 981325 — ACP
The FDA completed an inspection of ACP on Jul 8, 2016 in Montreuil Bellay. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Montreuil Bellay (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |