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806242

Buckeye International Inc — FEI 3001419679

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2012
Fiscal Year
2013
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))
  • 963414 (VAI Tue Jan 12 2016 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121521 CFR 211.67(b)Written procedures not established/followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188321 CFR 211.165(a)Testing and release for distribution
241921 CFR 211.198(a)Complaint Handling Procedure