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857538

Cryo-Cell International, Inc — FEI 2246948

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2013
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Oldsmar, FL (United States)

Facility

Other inspections at this facility

  • 1231513 (NAI Mon Jan 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165696 (NAI Wed Mar 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048890 (NAI Tue Feb 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026394 (VAI Tue Sep 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949175 (NAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1239821 CFR 1271.230(a)Validation & approval--established procedures
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV