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806879

Accugen Laboratories, Inc. — FEI 3003286168

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Addison, IL (United States)

Facility

Other inspections at this facility

  • 1229754 (VAI Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906015 (NAI Tue Dec 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 631689 (VAI Wed Dec 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action