The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s July 2017 inspection of American CryoStem’s New Jersey facility.

In a related press release, the agency cited the company as the latest in a series of stepped up enforcement activities to implement its comprehensive policy framework released in November 2017.

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