FDA 483 - Liveyon Labs Inc - May 23, 2019

This FDA Form 483 was issued to Liveyon Labs Inc, a biological drug manufacturer located at 22667 Old Canal Rd, Yorba Linda, CA, following an inspection from May 13-23, 2019. The Chief Compliance Officer, Erin M. Sairafe, was the recipient.

The inspection revealed nine observations:

1. **Inadequate Donor Screening:** Donors of umbilical cord blood were not properly screened for communicable disease agents, specifically Zika virus (ZIKV) and Creutzfeldt-Jakob Disease (CJD). The supplier's "Donor Risk Assessment Interview" form lacked critical questions regarding ZIKV exposure and CJD diagnosis. Since January 2019, Liveyon Labs received (b)(4) umbilical cord blood units from a ZIKV active transmission area, producing (b)(4) vials, with (b)(4) distributed.

2. **Improper Donor Eligibility Determination:** HCT/P donors were not deemed eligible based on complete screening and testing results, particularly concerning Zika and CJD risks from the main supplier in an active transmission area.

3. **Lack of Aseptic Process Validation:** Procedures to prevent microbiological contamination of sterile drug products did not include validation of the aseptic process. Since January 16, 2019, the firm processed (b)(4) donations into (b)(4) vials, distributing (b)(