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839549

Tropichem Research Labs LLC — FEI 1000113165

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Jupiter, FL (United States)

Facility

Other inspections at this facility

  • 1074424 (VAI Fri Dec 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001723 (VAI Tue Feb 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991207 (VAI Wed Jun 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826293 (VAI Tue Apr 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 721466 (VAI Fri Apr 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
191421 CFR 211.166(a)Lack of written stability program
360321 CFR 211.160(b)Scientifically sound laboratory controls