FDA Inspection 1196589 — De Soutter Medical Ltd
The FDA completed an inspection of De Soutter Medical Ltd on Feb 2, 2023 in ASTON CLINTON. 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
- Feb 2, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- ASTON CLINTON (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |