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841046

Advance Pharmaceutical Inc — FEI 2434807

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 2, 2013
Fiscal Year
2013
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
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
155021 CFR 211.125(f)Procedures Written and Followed
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures