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912138

QuVa Pharma, Inc. — FEI 3002468086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 23, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Temple, TX (United States)

Facility

Other inspections at this facility

  • 1172047 (VAI Thu Jun 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083122 (OAI Thu Mar 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995263 (VAI Thu Dec 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885230 (OAI Fri Jun 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871355 (OAI Wed Apr 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
440221 CFR 211.192Written record of investigation incomplete