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1210597

Vericel Corporation — FEI 3002836339

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 21, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
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))
  • 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))
  • 608350 (VAI Fri Aug 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
358321 CFR 211.110(a)Written in-process control procedures
361621 CFR 211.165(d)Acceptance criteria for sampling & testing