FDA Investigator Says Stem Cell Clinic Lacked Documentation

Law360 (May 11, 2021, 10:21 PM EDT) -- A U.S. Food and Drug Administration investigator told a California federal judge Tuesday about deficiencies she noted at a clinic being sued by the government over experimental stem cell treatments, including a lack of central documentation on adverse events such as a patient suffering retinal detachment after receiving eye injections.

Cynthia Jim testified during the second week of the bench trial that she has been a consumer safety officer with the FDA since 1994 and had conducted an eight-day inspection at the California Stem Cell Treatment Center in Rancho Mirage in 2017 amid concerns that the facility was manufacturing drugs without...

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