Home / Inspections / 739999

739999

Covis Pharma GmBH — FEI 3008152278

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 3, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Waltham, MA (United States)

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))
  • 981007 (VAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892953 (NAI Mon Jul 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
439121 CFR 211.180(e)(2)Items to cover on annual reviews
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications
891221 CFR 314.81(b)(2)Timely submission