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1017139

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Holtsville, NY (United States)

Facility

Other inspections at this facility

  • 1262179 (VAI Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074294 (VAI Thu Dec 13 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
201721 CFR 211.188(b)(5)In-Process and Laboratory Control Results
240121 CFR 211.194(a)(4)Complete Test Data
358821 CFR 211.110(a)(3)Mixing adequacy
360321 CFR 211.160(b)Scientifically sound laboratory controls