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1014041

Qualgen, LLC — FEI 3011286349

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 10, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Edmond, OK (United States)

Facility

Other inspections at this facility

  • 1230061 (VAI Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180879 (VAI Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144481 (OAI Tue Jun 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067476 (OAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945189 (OAI Thu Sep 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
145221 CFR 211.113(b)Validation lacking for sterile drug products
188521 CFR 211.165(b)Microbiological testing
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures