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626585

AVEVA Drug Delivery Systems, Inc. — FEI 1000307689

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 4, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miramar, FL (United States)

Facility

Other inspections at this facility

  • 1216787 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097807 (NAI Fri Jul 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049851 (VAI Fri Apr 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879211 (VAI Fri Apr 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 742495 (VAI Wed Sep 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
127021 CFR 211.68(b)input/output verification
154121 CFR 211.125(b)Examination of issued labels
163721 CFR 211.130(e)Packaging line inspection after use
185121 CFR 211.84(e)Rejecting When Specifications Not Met
192721 CFR 211.166(b)Accelerated stability studies
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358321 CFR 211.110(a)Written in-process control procedures
430621 CFR 211.80(a)Written Procedures Not Followed
438921 CFR 211.198(a)Procedures to be written and followed
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages