Thursday, January 4, 2018

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell


The U.S. Food and Drug Administration today posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk. Continue reading.
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