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1066751

Avara Pharmaceutical Technologies, Inc. — FEI 3004998655

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Norman, OK (United States)

Facility

Other inspections at this facility

  • 1192124 (NAI Mon Oct 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773884 (NAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 683863 (NAI Mon Sep 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
145021 CFR 211.113(a)Procedures for non-sterile drug products
178721 CFR 211.80(a)Procedures To Be in Writing
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified