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This year, 12 people have been hospitalized with bacterial infections after being treated with stem cell products derived from umbilical cord blood and manufactured by Genetech, a biotech firm in San Diego and distributed by Liveyon in Irvine, California, according to a Centers for Disease Control and Prevention report out today (December 21).
In a November 29 warning letter, the Food and Drug Administration (FDA) listed the many problems it had found during an inspection of Genetech this June and gave the company 15 business days to respond with what it had done to correct the deficiencies. Then yesterday, the FDA issued a press release detailing its concerns about Genetech products, calling them “dangerous,” and noting that “deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.”
“The FDA is committed to advancing the field of cell-based regenerative ...
