FDA Inspection 953977 — AB MEDICA SAS
The FDA completed an inspection of AB MEDICA SAS on Dec 10, 2015 in Mery Sur Cher. 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
- Dec 10, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mery Sur Cher (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |