Theranos, Inc. – FDA 483, Sep 16, 2015

This FDA Form 483 was issued to Theranos, Inc., a medical device manufacturer located at 7333 Gateway Blvd., Newark, CA 94560, on September 16, 2015, following an inspection from August 25, 2015, to September 16, 2015. Ramesh Balwani is identified as the President and Chief Operations Officer.

The inspection revealed several observations:

1. **Unlisted Devices:** Theranos was found to be marketing and shipping a Class I exempt medical device in interstate commerce (California, Arizona, Pennsylvania) for which listing is required but had not been completed. 2. **Inadequate Complaint Procedures:** The written procedures for handling customer complaints (SOP-00174, Revision A, and CS SOP-05071, Revision A) did not accurately reflect the verbally described complaint handling process. The provided QA complaint log contained no logged complaints, while a subsequently provided log contained CTN-related complaints. 3. **Uninvestigated Complaints:** A specific complaint reported via NCR-01926 on January 30, 2015, regarding "difficulties in inspecting certain specimen quality. Reports were too opaque to be able to see clotting clearly," was not identified, investigated, or documented as a complaint in compliance with the written procedure, nor was it investigated for potential Medical