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696611

Lifebanc — FEI 3003409909

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 2, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Warrensville Heights, OH (United States)

Facility

Other inspections at this facility

  • 1191143 (NAI Mon Nov 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111717 (NAI Fri Nov 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022398 (NAI Fri Aug 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930447 (NAI Thu Jun 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 839887 (NAI Thu Jul 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action