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1149863

Cord for Life, Inc. — FEI 1000525281

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 26, 2021
Fiscal Year
2021
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Altamonte Springs, FL (United States)

Facility

Other inspections at this facility

  • 1073266 (OAI Fri Nov 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002027 (NAI Fri Jan 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923079 (NAI Tue Apr 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770230 (NAI Tue Feb 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 562502 (NAI Thu Feb 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
191421 CFR 211.166(a)Lack of written stability program
201121 CFR 211.188(a)Accurate reproduction
457621 CFR 211.192No written record of investigation