FDA Inspection 770685 — Tecres S.p.A.
The FDA completed an inspection of Tecres S.p.A. on January 26, 2012 in Sommacampagna. 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
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sommacampagna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |