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963414

Buckeye International Inc — FEI 3001419679

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 12, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Maryland Heights, MO (United States)

Facility

Other inspections at this facility

  • 1279208 (VAI Thu Aug 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097583 (VAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003414 (VAI Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 806242 (VAI Thu Oct 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709026 (VAI Fri Feb 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
113321 CFR 211.25(a)GMP Training Frequency
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
191821 CFR 211.166(a)(2)Stability sample storage conditions described
192021 CFR 211.166(a)(3)Valid stability test methods
192221 CFR 211.166(a)(4)Testing in same container - closure system
241921 CFR 211.198(a)Complaint Handling Procedure