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610893

Weeks & Leo Co Inc — FEI 1910338

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clive, IA (United States)

Facility

Other inspections at this facility

  • 1168338 (VAI Thu Apr 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153842 (NAI Mon Sep 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046209 (VAI Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921147 (VAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821676 (VAI Wed Feb 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
139321 CFR 211.103Yield calculations not verified by 2nd person
154521 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
191421 CFR 211.166(a)Lack of written stability program
202621 CFR 211.192Quality control unit review of records
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
363121 CFR 211.170(b)Investigation of reserve sample deterioration
430321 CFR 211.67(b)Written procedures fail to include