FDA WARNING_LETTER - Liveyon Labs Inc - May 23, 2019

The FDA issued a Warning Letter to Liveyon Labs Inc. and Liveyon LLC following an inspection from May 13-23, 2019. The firms process and distribute human umbilical cord blood-derived cellular products, PURE® and PURE PRO®, intended for orthopedic conditions via intra-articular injection. The FDA determined these products are unapproved drugs and biological products, not solely regulated as HCT/Ps, because they are not for homologous use and fail to meet other HCT/P criteria (21 CFR 1271.10(a)). A valid biologics license or an Investigational New Drug (IND) application is required, neither of which Liveyon possesses.

The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) and Current Good Tissue Practice (CGTP), posing potential safety concerns. Deficiencies include: 1. **Failure to screen donors:** Inadequate assessment for Zika virus and Creutzfeldt-Jacob disease. 2. **Failure to test donor specimens:** Use of non-FDA licensed/approved/cleared tests for Zika virus. 3. **Inadequate aseptic practices:** Unvalidated aseptic process (media fill batch sizes too small), high-risk co-processing of different donor units without proper tracking, unimplemented gowning procedures, and use of non-sterile "For research use only" components. 4. **Failure to investigate discrepancies:** Inadequate investigations into