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Kimera Labs manufactured and distributed exosome products (XoGlo® and XoGlo®Pro) and an amniotic fluid product (Amnio2X®) that the FDA determined were biologics requiring either an approved biologics license application (BLA) or an active investigational new drug (IND) application. The company lacked required approvals to market these products, with only XoGlo®Pro having an IND in effect as of May 2023, while the other products had no authorization for commercial distribution. The FDA's July 2022 inspection documented that Kimera was distributing these purportedly sterile biological products to practitioners and medical facilities nationwide without proper regulatory approval, constituting violations of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.