The hot issues are related to compliance, EU MDR and recalls.
The disgraced former CEO once oozed total confidence about her company and product, and in latest released footage says “I don’t know” more than 600 times during a 2017 deposition.
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.