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1024520

MEDA Manufacturing GmbH — FEI 3002808393

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 7, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cologne (Germany)

Facility

Other inspections at this facility

  • 990063 (NAI Fri Sep 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872188 (NAI Fri Nov 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 560082 (NAI Fri Jan 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
357321 CFR 211.101(b)Measured components for manufacturing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include