FDA Inspection 1250056 — ENESTIA BELGIUM NV (SHARP BELGIUM)
The FDA completed an inspection of ENESTIA BELGIUM NV (SHARP BELGIUM) on Sep 19, 2024 in Hamont-Achel. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 19, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hamont-Achel (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |