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1067624

Brio Pharmaceuticals Inc — FEI 1628196

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 3, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Houston, TX (United States)

Facility

Other inspections at this facility

  • 1096432 (VAI Thu Jul 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929358 (NAI Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871072 (VAI Fri Mar 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 762066 (VAI Thu Jan 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729706 (NAI Wed May 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure