FDA 483 - Broncus Medical Inc. - July 30, 2021

Broncus Medical Inc. in San Jose, CA, was inspected and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in complaint handling processes, including failures to adequately evaluate complaints for MDR reporting, timely closure of complaints, and proper investigation documentation. Additionally, the firm failed to adequately evaluate potential suppliers, specifically regarding on-site audits for critical component providers.