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

This FDA Form 483 document outlines observations made during an inspection of a medical device manufacturing facility. The inspection revealed several deficiencies related to the company's design control processes and documentation practices.

Specifically, the design validation process was found to be inadequate, as it did not ensure the device conformed to defined user needs and intended uses. Furthermore, the design was not validated under actual or simulated use conditions, which is a critical step in ensuring device safety and efficacy.

Regarding design input, the document states that design input requirements were not adequately documented. This lack of proper documentation can lead to misunderstandings and errors throughout the design process. Additionally, the results of the design risk analysis were not adequately documented, indicating a potential gap in identifying and mitigating risks associated with the device.

Finally, a general documentation control issue was noted: documents were not reviewed and approved by designated individual(s) prior to issuance. This suggests a systemic problem in the company's quality system, potentially affecting the reliability and integrity of various operational documents beyond just design controls. These observations indicate a need for significant improvements in the facility's design control procedures and overall quality management system to ensure compliance with regulatory requirements.