Home / Inspections / 756036

756036

Corden Pharma S.p.A. — FEI 3002880938

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 28, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Caponago (Italy)

Facility

Other inspections at this facility

  • 1207569 (VAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124670 (VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061242 (VAI Tue Jul 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981653 (VAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881536 (VAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
116221 CFR 211.28(a)Protective Apparel Not Worn
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
200921 CFR 211.188Prepared for each batch, include complete information
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls