FDA WARNING_LETTER - EUCYT Laboratories LLC - November 21, 2019

On June 4, 2020, the FDA issued a Warning Letter to EUCYT Laboratories, LLC (EUCYT) following an inspection from November 12-21, 2019. The inspection documented EUCYT's manufacture and distribution of human umbilical cord blood and umbilical cord-derived products (VidaCord™, VidaGel™, VidaStem™), an exosome product (XOsomes™), and an amniotic fluid-derived product (VidaFlo™), all for allogeneic use. These products are intended for clinical use and are classified as drugs and biological products under the FD&C Act and PHS Act, and some as HCT/Ps.

EUCYT's HCT/Ps do not meet the criteria for regulation solely under section 361 of the PHS Act, specifically failing the homologous use criterion (21 CFR 1271.10(a)(2)) and minimal manipulation (21 CFR 1271.10(a)(1)) for VidaGel™ and VidaCord™. VidaStem™ also fails 21 CFR 1271.10(a)(4). The exosome products, XOsomes™ and COVIXO (marketed for COVID-19), are unapproved drugs and biological products requiring a valid biologics license or an IND, neither of which EUCYT possesses.

The inspection revealed significant