FDA Inspection 1303344 — Prodimed
The FDA completed an inspection of Prodimed on Feb 19, 2026 in Neuilly En Thelle. 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
- Feb 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Neuilly En Thelle (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 23141 | ISO 13485:2016 Clause 7.4.1 | Supplier monitoring and re-evaluation not planned |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |