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824487

CorneaGen - Boston — FEI 1000513310

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Waltham, MA (United States)

Facility

Other inspections at this facility

  • 1121216 (NAI Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068364 (NAI Wed Sep 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941531 (NAI Thu Aug 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 651853 (NAI Fri Mar 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1236321 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
1239821 CFR 1271.230(a)Validation & approval--established procedures
1240521 CFR 1271.250(a)Controlling the labeling of HCT/Ps