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909929

Evonik Operations GmbH — FEI 3002911044

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 12, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Marl (Germany)

Facility

Other inspections at this facility

  • 1289284 (VAI Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122166 (NAI Tue Feb 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772140 (NAI Tue Feb 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
181021 CFR 211.160(a)Lab controls established, including changes
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action