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729308

Exelead, Inc. — FEI 1000517970

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2011
Fiscal Year
2011
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
145121 CFR 211.113(b)Procedures for sterile drug products
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.