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1256355

Kutol Products Company, Inc. — FEI 1513988

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 4, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sharonville, OH (United States)

Facility

Other inspections at this facility

  • 1119429 (VAI Tue Mar 03 2020 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
188521 CFR 211.165(b)Microbiological testing
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
441321 CFR 211.194(a)(8)Second person sign off