FDA 483 - Zoe Medical Incorporated - September 20, 2019

During an inspection conducted from September 18-20, 2019, Zoe Medical Incorporated, a medical device manufacturer located in Topsfield, MA, received an FDA Form 483. The inspection highlighted a significant observation regarding the company's quality system. The primary issue identified was the lack of documented evaluation for potential suppliers. Specifically, Zoe Medical Incorporated failed to document its assessment of the vendor supplying a critical component for its 740 Select Multi-Parameter Monitor, a Class II medical device. This component has been purchased from the supplier since November 2017 without proper documentation of the supplier's evaluation. This observation indicates a deviation from regulatory requirements concerning quality system controls for medical device manufacturing. The FDA emphasizes that such documentation is crucial for ensuring the quality and safety of medical devices. As a required action, Zoe Medical Incorporated is responsible for conducting thorough internal self-audits to identify and rectify all violations of quality system requirements to ensure compliance and maintain product integrity.