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1092034

Grace Analytical Lab Inc — FEI 3007291509

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 30, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Berkeley, IL (United States)

Facility

Other inspections at this facility

  • 1153105 (VAI Wed Sep 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007614 (OAI Mon Jan 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870581 (NAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 750556 (NAI Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681349 (VAI Thu Sep 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
113621 CFR 211.25(c)Inadequate number of personnel
126321 CFR 211.68(b)Computer control of master formula records
189021 CFR 211.165(e)Test methods
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
203321 CFR 211.194(c)Testing and standardization of standards et. al.
360221 CFR 211.160(a)Deviations from laboratory control requirements
361321 CFR 211.160(b)(4)Establishment of calibration procedures
440621 CFR 211.194(a)(2)Suitability of testing methods verified