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872698

Eversight — FEI 3001236615

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 2, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Clark, NJ (United States)

Facility

Other inspections at this facility

  • 1178408 (NAI Thu Aug 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079760 (VAI Tue Feb 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986660 (NAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793821 (NAI Thu Aug 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 632949 (NAI Fri Dec 04 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1239821 CFR 1271.230(a)Validation & approval--established procedures
1240821 CFR 1271.250(c)All labeling requirements met