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654681

Chiesi USA, Inc. — FEI 3006389494

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 24, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cary, NC (United States)

Facility

Other inspections at this facility

  • 1247140 (NAI Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062125 (NAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918260 (NAI Fri Mar 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918223 (NAI Wed Mar 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801466 (NAI Thu Sep 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
185121 CFR 211.84(e)Rejecting When Specifications Not Met
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.