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1049851

AVEVA Drug Delivery Systems, Inc. — FEI 1000307689

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2018
Fiscal Year
2018
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))
  • 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))
  • 626585 (OAI Fri Dec 04 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
241921 CFR 211.198(a)Complaint Handling Procedure
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
439121 CFR 211.180(e)(2)Items to cover on annual reviews