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654651

Saving Sight — FEI 3001238378

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 30, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Springfield, MO (United States)

Facility

Other inspections at this facility

  • 1281320 (NAI Wed Aug 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047338 (NAI Thu Mar 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956004 (NAI Thu Dec 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896676 (NAI Fri Sep 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1241421 CFR 1271.260(d)Corrective actions
1242721 CFR 1271.265(c)(3)HCT/Ps made under departure from process
1247221 CFR 1271.350(b)(1)Deviations not investigated
1247321 CFR 1271.350(b)(2)Deviations not reported to FDA