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

The FDA issued a Warning Letter to Safari Stem Cell, LLC, following an inspection from May 1-4, 2023. Safari Stem Cell recovers, processes, and distributes cell- and tissue-based products, including platelet-rich plasma, conditioned media, and stem cells from canine and feline donors, for autologous, allogeneic, or xenogeneic uses. These products are intended to treat various animal diseases and conditions, such as IVDD, CKD, IMHA, diabetes mellitus type II, IBD, keratoconjunctivitis, inflammatory disorders, arthritis, and hip dysplasia, administered intravenously, intra-articularly, and intrathecally.

The FDA determined these products are unapproved new animal drugs under section 201(g)(1)(B) and 201(v) of the FD&C Act, making them unsafe (section 512(a)) and adulterated (section 501(a)(5)). Safari's website and social media continue to market these products despite a May 12, 2023, statement that the firm would cease operations.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations, causing the products to be adulterated under section 501(a)(2)(B) of the FD&C Act. Deficiencies include: 1. Failure to establish written production and process control procedures (21 CFR