FDA EIR - Theranos, Inc. - August 16, 2016

An FDA inspection of Theranos, Inc., located in Palo Alto, CA, was conducted from August 16 to August 18, 2016. This inspection specifically targeted the company's sponsor monitoring activities for a clinical study involving two device protocols, under the regulatory framework of the Division of Bioresearch Monitoring within the Center for Devices and Radiological Health (CDRH).

The primary violation, documented in an FDA Form 483, was the initiation of parts of the clinical investigation, specifically for a significant number of samples, without prior Institutional Review Board (IRB) approval, contravening 21 CFR 812.42. Additional significant issues included the clinical trial not being registered on clinicaltrials.gov, clinical investigators failing to sign required FDA Investigator Agreement Forms (Form 1572) or Financial Disclosure Forms, and the investigational device lacking proper labeling as mandated by 21 CFR 812.5. The inspection also identified deficiencies in recordkeeping, an absence of on-site study monitoring, and undocumented verification of subject inclusion/exclusion criteria.

In response, Theranos management acknowledged the findings, committing to provide a written response to the FDA 483 within 15 business days. The company also indicated an intent to withdraw a related submission. Management expressed an understanding of the regulatory focus and a commitment to enhance their processes.