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1207713

CorneaGen Inc. — FEI 3005357288

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 31, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Winston Salem, NC (United States)

Facility

Other inspections at this facility

  • 1149011 (NAI Wed Jul 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061992 (NAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946041 (NAI Thu Oct 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870037 (NAI Fri Feb 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773966 (NAI Thu Mar 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1236321 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
1238121 CFR 1271.210(d)(2)Verification elements