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554200

Kath Khemicals LLC — FEI 3000719870

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 30, 2008
Fiscal Year
2009
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))
  • 805646 (VAI Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699038 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
139521 CFR 211.103Actual vs. theoretical yields not determined
178721 CFR 211.80(a)Procedures To Be in Writing
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
202621 CFR 211.192Quality control unit review of records
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
356521 CFR 211.58Buildings not maintained in good state of repair
358321 CFR 211.110(a)Written in-process control procedures
361321 CFR 211.160(b)(4)Establishment of calibration procedures
440421 CFR 211.194(a)(1)Sample identification and other information