The disgraced company founder Holmes and its former President Sunny Balwani have been charged with raising more than $700 million from investors in a massive fraud scheme.
Agency sanctions include a monetary penalty and revocation of the lab’s CLIA certificate.
In a Today Show interview, Elizabeth Holmes voices responsibility felt as a result of company problems.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.