https://www.siliconvalley.com/2021/10/14/elizabeth-holmes-trial-theranos-put-patients-in-immediate-jeopardy-regulator-warned/

Elizabeth Holmes’ blood-testing company Theranos put patients in “immediate jeopardy” and failed to resolve regulators’ concerns over its laboratory practices and staff training, according to a government report filed Wednesday in connection with her criminal fraud trial.

The U.S. Centers for Medicare & Medicaid Services, which regulates laboratories, noted in a 2016 letter to Holmes and her former Theranos president Sunny Balwani that it had found serious deficiencies in the firm’s Bay Area laboratory, and that the company’s responses to the alleged violations were not sufficient or credible. Patients using Theranos blood testing, the letter said, were still in “immediate jeopardy” in which serious harm or death may occur.