FDA Inspection 915947 — Tecres S.P.A.
The FDA completed an inspection of Tecres S.P.A. on Feb 5, 2015 in Sommacampagna. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 5, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sommacampagna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |