Home / Inspections / 993004

993004

Dharma Research, Inc. — FEI 3010131268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 1, 2016
Fiscal Year
2017
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))
  • 1180969 (VAI Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083281 (VAI Mon Mar 18 2019 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
108621 CFR 211.22(b)Adequate lab facilities not available
110521 CFR 211.22(d)Procedures not in writing, fully followed
194321 CFR 211.180(e)(1)Review of representative number of batches
200921 CFR 211.188Prepared for each batch, include complete information
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
360321 CFR 211.160(b)Scientifically sound laboratory controls