FDA Inspection 1308072 — medicalplastic
The FDA completed an inspection of medicalplastic on March 19, 2026 in Milan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Milan (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23222 | ISO 13485:2016 Clause 8.2.4 | Internal audit program not planned |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |