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981007

Covis Pharma GmBH — FEI 3008152278

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 15, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Waltham, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1250807 (NAI Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087302 (NAI Fri Apr 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071326 (NAI Mon Oct 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892953 (NAI Mon Jul 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878312 (VAI Wed May 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
673521 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events