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Re-Gen Active Lab, Inc. manufactured and distributed three cellular products (ActiveFlow™, ActiveShot™, and ActivePro™) derived from amniotic membrane and umbilical cord tissue for injection, which the FDA determined were drugs and biological products intended to treat various diseases or conditions rather than qualifying for regulation solely as human cells, tissues, or cellular products (HCT/Ps) under section 361 of the PHS Act. The company failed to comply with 21 CFR Part 1271 requirements for HCT/Ps and did not qualify for applicable regulatory exceptions, making the products subject to additional premarket review requirements as drugs and biological products under the FD&C Act and PHS Act. The FDA conducted an inspection between July 19-28, 2021, and documented that Re-Gen Active Lab had distributed these products directly to third-party distributors, physicians, and medical clinics throughout the United States without appropriate FDA authorization.