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857676

Fougera Pharmaceuticals Inc. — FEI 2432435

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 31, 2013
Fiscal Year
2014
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))
  • 1177370 (VAI Wed Aug 10 2022 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))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
358321 CFR 211.110(a)Written in-process control procedures