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783684

Exelead, Inc. — FEI 1000517970

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1287394 (VAI Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1225603 (VAI Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062147 (VAI Mon Jul 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922118 (VAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878732 (VAI Fri May 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
162621 CFR 211.130Procedures are written, and followed
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
358221 CFR 211.105(a)Identification of containers, lines, equipment
358521 CFR 211.110(a)Control procedures to monitor and validate performance