FDA 483 - Ningbo Besmed Medical Equipment Corp. - June 12, 2019

An FDA inspection of NINGBO BESMED MEDICAL EQUIPMENT, a Class II Device Manufacturer in Ningbo, China, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for process validation, deviation documentation, equipment calibration, and employee training. These issues indicate a lack of robust controls over critical manufacturing processes and quality assurance.