FDA 483 - BioStem Life Sciences - September 15, 2023

BioStem Life Sciences in Pompano Beach, FL, a manufacturer of amniotic fluid/membrane and umbilical cord derived products, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately validate manufacturing processes, conduct final product testing for identity and strength prior to release, and establish expiration dates based on appropriate stability data. These issues indicate a lack of adequate controls to assure product quality and purity.