FDA Inspection 1249526 — S.M.A.I.O

S.M.A.I.O — FEI 3015383864

The FDA completed an inspection of S.M.A.I.O on Sep 19, 2024 in Saint-Priest Metropole de Lyon. 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
Postmarket Assurance: Devices
Location
Saint-Priest Metropole de Lyon (France)

Citations

IDCFRDescription
243021 CFR 820.30(b)Design plans - Lack of or inadequate