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Smart Surgical, Inc dba Burst Biologics manufactured and distributed human umbilical cord blood-derived products (BioBurst Fluid and BioBurst Rejuv) intended for injection to treat various diseases, which the FDA determined were biologics and drugs requiring premarket review rather than products that could be regulated solely under section 361 of the Public Health Service Act. The company's human cell, tissue, and cellular products (HCT/Ps) failed to meet the criteria in 21 CFR 1271.10(a) and did not qualify for any applicable exemption under 21 CFR 1271.15, placing them outside the scope of products exempt from full drug and biological product regulation. The FDA's inspection between February and March 2021 documented these regulatory violations and the company's failure to comply with applicable HCT/P regulations under 21 CFR Part 1271.