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1119429

Kutol Products Company, Inc. — FEI 1513988

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 3, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sharonville, OH (United States)

Facility

Other inspections at this facility

  • 1256355 (OAI Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 943842 (VAI Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861942 (VAI Thu Jan 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801788 (VAI Thu Oct 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 658346 (VAI Fri Apr 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
438921 CFR 211.198(a)Procedures to be written and followed