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999079

Charles River Laboratories, Inc. — FEI 3006088423

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Shrewsbury, MA (United States)

Facility

Other inspections at this facility

  • 1284252 (NAI Wed Sep 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072800 (NAI Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699489 (VAI Wed Dec 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440221 CFR 211.192Written record of investigation incomplete
440321 CFR 211.194(b)Test method modification records do not include