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
- 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...