FDA Inspection 1113204 — Future Diagnostics Solutions B.V.
The FDA completed an inspection of Future Diagnostics Solutions B.V. on Dec 12, 2019 in Wijchen. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wijchen (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |