FDA 483 - Theranos, Inc. - September 16, 2015

Theranos, Inc., a medical device manufacturer in Newark, CA, was inspected by the FDA from August 25 to September 16, 2015. The inspection revealed significant deficiencies across its quality management system, including unlisted medical devices, inadequate complaint handling, undocumented corrective actions, unvalidated software, and poor supplier controls. These findings indicate a systemic failure to comply with medical device regulations.