FDA 483 - Bing Innovations Llc - October 11, 2023

An FDA inspection of Bing Innovations Llc, a medical device manufacturer, was conducted from October 11 to October 17, 2023. The inspection resulted in the issuance of an FDA Form 483, detailing seven significant observations indicating a critical lack of fundamental quality management system elements.

Key issues included the absence of a designated management representative to oversee the quality system and report on its performance. The firm also failed to establish essential quality system procedures and a comprehensive quality policy. Furthermore, there were no documented procedures for training personnel, nor had any staff received training on critical regulatory aspects such as quality system regulations, labeling, medical device reporting, recalls, establishment registration, device listing, and unique device identification.

Additional observations highlighted the lack of established procedures for corrective and preventive actions (CAPA), with no CAPA activities initiated. Complaint handling procedures were found inadequate, with no formal process for receiving, evaluating, or investigating complaints, or for determining reportability under Medical Device Reporting regulations. The inspection also revealed a lack of purchasing controls, meaning the firm had not established procedures for evaluating suppliers, contractors, and consultants, nor did it have agreements requiring notification of changes affecting device quality. Finally, there were no established procedures for conducting quality audits, and no audits had been performed.

To address these observations, Bing Innovations Llc is required to develop and implement a robust quality management system that encompasses all the deficient areas, ensuring compliance with medical device quality system regulations.