Health Law & Business News

Unapproved Umbilical Cord Products Bring Rebuke From FDA

Dec. 10, 2019, 7:45 PM

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Liveyon Labs Inc.

  • Issuing Office: Food and Drug Administration, Office of Biological Products Operations
  • Recipient: Roya Panah (president and chief executive officer)
  • Date: Dec. 5 (posted Dec. 10)
  • Inspection of facility in Yorba Linda, Calif., May 13-23

Alleged Infractions

  • Marketed umbilical cord products without a valid biologics license, approved new drug application, or approved biologics license application.
  • Failed to review cell and tissue donors for exposure to Zika virus, or evidence of Creutzfeldt-Jacob disease.
  • Tested umbilical cord blood donors for...
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