FDA WARNING_LETTER - Stratus BioSystems, LLC - November 10, 2021

On June 5, 2023, the FDA issued a Warning Letter to Stratus Biosystems, LLC (dba CellGenuity Regenerative Science or CellGenuity) following an inspection from October 26 to November 10, 2021. The letter addresses the manufacture and distribution of allogeneic umbilical cord and amniotic membrane derived product, AmnioAMP-WJ™, and amniotic fluid derived product, AmnioAllograft, intended for injection and purported to be sterile.

The FDA determined these products are unapproved new drugs and biological products requiring a Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which are in effect. AmnioAMP-WJ™ is also an HCT/P that fails to meet the homologous use criterion under 21 CFR 1271.10(a)(2), making it subject to drug/biologic regulations. Amniotic fluid products like AmnioAllograft are generally regulated as drugs and biological products.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) deviations, including: 1. Failure to establish and follow written procedures to prevent microbiological contamination, including validation of aseptic processes and environmental monitoring (21 CFR 211.113(b)). 2. Inadequate cleaning and disinfection systems for aseptic conditions (21 CFR 211.42(c)(