FDA WARNING_LETTER - Row1 Inc. dba Regenative Labs - March 30, 2022

On June 21, 2023, the FDA issued a Warning Letter to Row1, Inc. (dba Regenative Labs) following an inspection from March 21-30, 2022. The inspection documented the manufacture and distribution of human umbilical cord-derived cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro), intended for injection and purporting to be sterile.

The FDA determined these products are drugs and biological products, not solely HCT/Ps, because they fail to meet the homologous use and minimal manipulation criteria under 21 CFR 1271.10(a). Consequently, they require an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which Regenative Labs possesses.

The letter also cited significant Current Good Manufacturing Practice (CGMP) deviations for over (b)(4) vials manufactured between February 2020 and March 2022. Violations include: 1. Failure to validate aseptic processes and establish appropriate environmental monitoring procedures (e.g., high action limits for microbiological monitoring, no non-viable particulate monitoring, inadequate personnel practices). 2. Failure to validate manufacturing processes for identity, strength, quality, and purity. 3. Failure to establish a written stability testing program to support the assigned five