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Vitti Labs manufactured and distributed human cell and tissue products derived from umbilical cord and amniotic membrane (EV-PURE+, WJ-PURE+, VITTI-PURE, NS-PURE, and EV-OPTI DROPS) for clinical use in treating various human diseases, which classified them as drugs and biological products requiring FDA approval rather than being regulated solely under section 361 of the PHS Act. The company failed to comply with 21 CFR Part 1271 requirements for human cells, tissues, and cellular or tissue-based products (HCT/Ps), marketing sterile products intended for injection, ophthalmic, and topical administration without meeting the necessary regulatory criteria. The FDA conducted an inspection between December 6-20, 2021, and found that Vitti Labs had distributed these unapproved biologics directly to healthcare professionals and medical facilities as well as through third-party distributors under private labeling arrangements.