Source: MedPage Today 

The FDA has issued a warning letter to Safari Stem Cell, a Texas-based company producing stem cell and platelet-rich plasma products for pets. The agency noted that Safari Stem Cell claims its products can treat various animal diseases, including arthritis and kidney disease, without proper FDA approval. The company’s products, derived from cat and dog tissues, are classified as animal drugs, requiring FDA regulation and an approved “new animal drug application,” which Safari Stem Cell lacks.

During an inspection, the FDA found significant deviations from Current Good Manufacturing Practice (CGMP) regulations, including inadequate written protocols, microorganism testing, and environmental monitoring. Although Safari Stem Cell had previously stated it would cease operations in response to these violations, it continued to promote and sell its products. The company’s president, Steven Garner, indicated efforts to comply with FDA regulations, such as building a new CGMP-compliant lab and updating protocols. The company is awaiting a response from the FDA after submitting a formal response to the warning letter.

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