FDA 483 - Safari Stem Cell, LLC - January 10, 2025

Safari Stem Cell, LLC, an animal stem cell product manufacturer in League City, TX, was cited for significant deficiencies during an FDA inspection. The firm failed to establish adequate production controls, sterility testing, product specifications, and environmental monitoring for its culture-expanded allogeneic adipose-derived cell products. Many of these issues are repeat observations, indicating persistent non-compliance and a prior Warning Letter.