FDA Inspection 846911 — C.S.O. S.R.L.

C.S.O. S.R.L. — FEI 4196

The FDA completed an inspection of C.S.O. S.R.L. on September 4, 2013 in Scandicci. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 4, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Scandicci (Italy)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures