FDA 483 - Ningbo Besmed Medical Equipment Corp. - May 15, 2025

An FDA inspection of Ningbo Besmed Medical Equipment Corp. in Ningbo, China, revealed significant deficiencies across its quality system for medical device manufacturing, particularly concerning disposable nebulizer sets. The firm failed to establish adequate procedures for complaint handling, non-conforming product control, finished device acceptance, process controls, incoming product acceptance, labeling, and Medical Device Reporting. Additionally, device history records were incomplete, and product contamination prevention procedures were lacking, indicating systemic issues in maintaining product quality and regulatory compliance.