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1177370

Fougera Pharmaceuticals Inc. — FEI 2432435

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Melville, NY (United States)

Facility

Other inspections at this facility

  • 1226533 (NAI Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099025 (VAI Thu Aug 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053495 (VAI Tue May 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992924 (VAI Thu Nov 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908064 (VAI Tue Dec 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
188521 CFR 211.165(b)Microbiological testing
360321 CFR 211.160(b)Scientifically sound laboratory controls