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871072

Brio Pharmaceuticals Inc — FEI 1628196

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 21, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
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))
  • 1067624 (VAI Wed Oct 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929358 (NAI Mon Jun 01 2015 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
119421 CFR 211.42(c)Defined areas of adequate size for operations
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
178721 CFR 211.80(a)Procedures To Be in Writing
189021 CFR 211.165(e)Test methods
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
430321 CFR 211.67(b)Written procedures fail to include