The FDA has recently issued a warning letter to Safari Stem Cell, a Texas-based company that produces stem cell and platelet-rich plasma products for pets. The agency raised concerns about the company’s claims that its products can treat a variety of diseases in animals, including arthritis, kidney disease, dry eye, and intervertebral disc disease. These claims were found to lack proper approval, as the products should be considered animal drugs subject to FDA regulation. Safari Stem Cell was also cited for “significant deviations” from Current Good Manufacturing Practice (CGMP) regulations during an inspection. These deviations included the lack of written protocols to ensure product quality, failure to test for microorganisms, and failure to monitor environmental conditions in an aseptic area.
Steven Garner, the president of Safari Stem Cell, has stated that the company has taken steps to address the FDA’s concerns. This includes building a new CGMP compliant lab, updating standard operating procedures, and protocols. Garner expressed confidence in the company’s ability to address the allegations and emphasized their goal of treating untreatable fatal diseases of pets with stem cells. He also mentioned that the company has been in operation for over 10 years without prior notice from the FDA, indicating a difference of opinion but willingness to work with consultants on moving forward. Despite an earlier notice to cease operations in response to violations in May 2023, the company continued to promote and sell products on their website, leading to the warning letter issued in April 2024.
Following the FDA warning letter, Safari Stem Cell provided a formal response to the agency and is awaiting a response. Garner stated that the company submitted their initial response within the required timeframe and completed tasks outlined in the response, awaiting further guidance from the FDA. The warning letter is part of the FDA’s efforts to regulate unapproved regenerative medicine therapies, expanding beyond human products to include animal products like those produced by Safari Stem Cell. The agency has been addressing noncompliant versions of these products since 2021 and now requires manufacturers to meet premarket approval criteria or conduct research under investigational new drug requirements.
Safari Stem Cell’s receipt of a warning letter from the FDA highlights the importance of regulatory oversight in the production and marketing of stem cell products for pets. The agency’s concerns about unapproved claims, deviations from manufacturing regulations, and lack of proper approval underscore the need for companies in this sector to adhere to FDA guidelines. Moving forward, Safari Stem Cell will need to continue to address the agency’s concerns, work towards compliance with FDA regulations, and ensure the safety and efficacy of their products for pets.
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