1026500

BR SAS — FEI 1000373305

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 22, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Suresnes (France)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews
457621 CFR 211.192No written record of investigation