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Row1 Inc. dba Regenative Labs manufactured and distributed human cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro) derived from umbilical cord tissue that were intended for clinical use to treat various diseases through injection and other routes of administration. The company failed to comply with FDA regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) under 21 CFR Part 1271 and did not qualify for any regulatory exceptions, meaning the products were required to undergo premarket review as drugs and biological products under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The inspection conducted in March 2022 found that the company was distributing these unapproved cellular products to physicians and medical clinics throughout the United States without proper FDA authorization.