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Stratus Biosystems, LLC (operating as CellGenuity Regenerative Science) manufactured and distributed allogeneic cell and tissue products derived from umbilical cord, amniotic membrane, and amniotic fluid intended for injection to treat various diseases, which qualified as biological products and human cells, tissues, or cellular and tissue-based products (HCT/Ps) subject to FDA regulation under 21 CFR Part 1271. The company failed to comply with HCT/P regulatory requirements, specifically not meeting the criteria outlined in 21 CFR 1271.10(a), which governs eligibility and manufacturing standards for these products. The violations were identified during an FDA inspection conducted between October 26 and November 10, 2021, at the company's Grapevine, Texas facility.