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731542

Weeks & Leo Co Inc — FEI 1910338

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 27, 2011
Fiscal Year
2011
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
1575021 CFR 111.210(d)Master manufacturing record - ingredients list
1581721 CFR 111.570(b)(2)(ii)(F)Record - product complaint; findings
1586421 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
202621 CFR 211.192Quality control unit review of records
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
357021 CFR 211.100(a)Approval and review of procedures
430621 CFR 211.80(a)Written Procedures Not Followed
432921 CFR 211.122(b)Rejection of unapproved labeling/packaging materials
439121 CFR 211.180(e)(2)Items to cover on annual reviews
457621 CFR 211.192No written record of investigation