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1001330

Vetter Pharma Fertigung GmbH & Co. KG — FEI 3002808846

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Langenargen (Germany)

Facility

Other inspections at this facility

  • 1205983 (VAI Tue May 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129699 (NAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070717 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031350 (VAI Fri Nov 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873643 (NAI Thu Feb 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified