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742495

AVEVA Drug Delivery Systems, Inc. — FEI 1000307689

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 28, 2011
Fiscal Year
2011
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))
  • 626585 (OAI Fri Dec 04 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
430621 CFR 211.80(a)Written Procedures Not Followed
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action