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1180969

Dharma Research, Inc. — FEI 3010131268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1256988 (VAI Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083281 (VAI Mon Mar 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993004 (VAI Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 893744 (VAI Fri Sep 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754510 (VAI Wed Nov 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
188521 CFR 211.165(b)Microbiological testing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
437621 CFR 211.188(b)(4)Weights and measures of components used