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879211

AVEVA Drug Delivery Systems, Inc. — FEI 1000307689

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2014
Fiscal Year
2014
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))
  • 742495 (VAI Wed Sep 28 2011 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
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
162621 CFR 211.130Procedures are written, and followed
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
439121 CFR 211.180(e)(2)Items to cover on annual reviews