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1085833

Lions Eye Bank For Long Island — FEI 3001518813

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 10, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Valley Stream, NY (United States)

Facility

Other inspections at this facility

  • 1213010 (VAI Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984391 (NAI Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880764 (NAI Fri Jun 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787772 (VAI Fri Jun 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 561545 (NAI Fri Feb 06 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1236921 CFR 1271.200(b)Procedures inadequate
1243321 CFR 1271.265(f)Return to inventory--procedures
1243621 CFR 1271.270(a)Accurate, indelible, legible