FDA Inspection 1228789 — Demcon Production B.V.
The FDA completed an inspection of Demcon Production B.V. on Feb 1, 2024 in Enschede. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 1, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Enschede (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |