Theranos, Inc. – FDA EIR, Sep 16, 2015

An FDA inspection of Theranos, Inc., a medical device manufacturer specializing in specimen containers located in Palo Alto, CA, was conducted between August 25, 2015, and September 16, 2015. This extensive review marked the first FDA inspection for the company. It was carried out under Compliance Program 7382.845, which specifically outlines procedures for inspecting medical device manufacturers to ensure product safety and quality. During the inspection, the FDA identified certain "Objectionable Conditions." While the document confirms these findings and includes sections for management's response and proposed "Voluntary Corrections," the specific details of the violations and the exact nature of the required remedial actions are heavily redacted throughout the report. This prevents a detailed enumeration of the issues encountered. However, the presence of these sections indicates that the inspection uncovered areas where the company's operations or products did not fully align with regulatory expectations, necessitating corrective measures from Theranos to ensure ongoing compliance with medical device regulations. The inspection underscores the critical importance of strict adherence to manufacturing and quality control standards in the medical device industry.