FDA Inspection 1236059 — AB MEDICA SAS
The FDA completed an inspection of AB MEDICA SAS on Mar 28, 2024 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 28, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mery Sur Cher (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |