FDA Inspection 1250056 — ENESTIA BELGIUM NV (SHARP BELGIUM)

ENESTIA BELGIUM NV (SHARP BELGIUM) — FEI 3002958688

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

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes