FDA 483 - Safari Stem Cell, LLC - May 04, 2023

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 fundamental written procedures for production and process controls, including process validation, sterility testing, and environmental monitoring for its culture-expanded allogeneic adipose-derived cell product. Additionally, the quality control unit was found to be severely lacking, with no written procedures for complaints, cleaning, or complete batch records, indicating a systemic failure to ensure product quality and safety.