FDA WARNING_LETTER - Re-Gen Active Lab, Inc. - July 28, 2021

On May 27, 2022, the FDA issued a Warning Letter to Re-Gen Active Lab, Inc. following an inspection from July 19-28, 2021. The inspection documented the manufacture and distribution of cellular products ActiveFlow™, ActiveShot™, and ActivePro™, derived from amniotic membrane and/or umbilical cord tissue, intended for injection and purported sterility. The FDA classified these products as unapproved drugs and biological products under the FD&C Act and PHS Act, and HCT/Ps under 21 CFR Part 1271, failing to meet homologous use and minimal manipulation criteria (21 CFR 1271.10(a)(1), (2)).

The firm lacks an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application for these products, violating 42 U.S.C. 262(a) and 21 U.S.C. 355(i).

Significant Current Good Manufacturing Practice (CGMP) deviations (21 CFR Parts 210 and 211) were identified, including: 1. Failure to validate aseptic processes and prevent microbiological contamination (21 CFR 211.113(b)), including inadequate personnel practices and environmental monitoring. 2. Failure to routinely calibrate equipment, specifically the Laminar Flow Hood (