FDA Inspection 725872 — Cousin Biotech SAS

Cousin Biotech SAS — FEI 3003258310

The FDA completed an inspection of Cousin Biotech SAS on May 25, 2011 in Wervicq-Sud. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 25, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Wervicq-Sud (France)

Citations

IDCFRDescription
333121 CFR 820.181DMR - not or inadequately maintained
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures