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805646

Kath Khemicals LLC — FEI 3000719870

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 1, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Macomb, MI (United States)

Facility

Other inspections at this facility

  • 1265697 (OAI Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034994 (VAI Thu Dec 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699038 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 554200 (VAI Tue Dec 30 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
180221 CFR 211.84(b)Representative Samples
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
202621 CFR 211.192Quality control unit review of records
363221 CFR 211.170(b)Annual visual exams of drug products
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies