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1210295

Dextrum Laboratories — FEI 3003092372

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 18, 2023
Fiscal Year
2023
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))
  • 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))
  • 965268 (VAI Fri Feb 12 2016 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
195621 CFR 211.180(e)(1)Representative Number of Batches for Annual Review
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.