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988950

Chiesi Farmaceutici S.p.A. — FEI 3002806655

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 29, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Parma (Italy)

Facility

Other inspections at this facility

  • 1270425 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1135697 (VAI Fri Nov 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062323 (VAI Thu Jul 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 738408 (VAI Fri Jul 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116321 CFR 211.28(b)Habits of good sanitation & health
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
457621 CFR 211.192No written record of investigation