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897666

Solupharm Pharmazeutische Erzeugnisse Gmbh — FEI 3008255368

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 22, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Melsungen (Germany)

Facility

Other inspections at this facility

  • 1201236 (VAI Fri Jul 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039841 (VAI Fri Feb 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980047 (VAI Tue Jun 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756529 (NAI Tue Nov 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
144921 CFR 211.111Deviations of production time limits
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls