FDA Inspection 940386 — FH Industrie
The FDA completed an inspection of FH Industrie on July 23, 2015 in Quimper. 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
- July 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Quimper (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |