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965268

Dextrum Laboratories — FEI 3003092372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 12, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1249319 (OAI Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210295 (OAI Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192929 (VAI Fri Dec 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031539 (VAI Fri Nov 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790155 (NAI Tue Jul 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
149521 CFR 211.122(a)Written procedures describing in detail
188321 CFR 211.165(a)Testing and release for distribution
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
432021 CFR 211.84(d)(6)Microbiological Contamination Exam