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608350

Vericel Corporation — FEI 3002836339

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 21, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Cambridge, MA (United States)

Facility

Other inspections at this facility

  • 1249999 (VAI Wed Sep 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210597 (NAI Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006746 (VAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870615 (VAI Wed Mar 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 747422 (VAI Tue Sep 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
358521 CFR 211.110(a)Control procedures to monitor and validate performance
432421 CFR 211.110(b)In-process materials specifications testing
440221 CFR 211.192Written record of investigation incomplete
908921 CFR 600.14(c)When to report
909521 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert