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995263

QuVa Pharma, Inc. — FEI 3002468086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2016
Fiscal Year
2017
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))
  • 912138 (VAI Fri Jan 23 2015 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
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
18008FDCA 503B(a)(10)Drug product label, outsourcer facility