FDA Inspection 1254348 — MEDICA S.P.A. Socio Unico
The FDA completed an inspection of MEDICA S.P.A. Socio Unico on Nov 15, 2024 in Medolla. 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
- Nov 15, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Medolla (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |