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1262179

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 27, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Holtsville, NY (United States)

Facility

Other inspections at this facility

  • 1074294 (VAI Thu Dec 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017139 (VAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953151 (OAI Wed Dec 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923025 (VAI Fri Mar 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859634 (VAI Thu Dec 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
140921 CFR 211.42(c)(4)In-Process Material Area
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
180921 CFR 211.160(a)Following/documenting laboratory controls