483
Safari Stem Cell, LLCSafari Stem Cell, LLC – FDA 483, Jan 10, 2025
Record Details
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.
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ID · ed813b6d-d91a-46d6-bd21-23cba8cd8fcd
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