FDA Inspection 922420 — Prodimed Plastimed Division
The FDA completed an inspection of Prodimed Plastimed Division on Mar 12, 2015 in Le Plessis-Bouchard. 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
- Mar 12, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Le Plessis-Bouchard (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |