FDA Inspection 1235538 — Efer Endoscopy

Efer Endoscopy — FEI 3006493107

The FDA completed an inspection of Efer Endoscopy on Apr 5, 2024 in La Ciotat. 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
Apr 5, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
La Ciotat (France)

Citations

IDCFRDescription
2279521 CFR 801.20(a)Label to bear a unique device identifier
337521 CFR 820.198(e)Records of complaint investigation