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709608

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2011
Fiscal Year
2011
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))
  • 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))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116221 CFR 211.28(a)Protective Apparel Not Worn
191421 CFR 211.166(a)Lack of written stability program
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews