FDA 483 - W.A. Baum Co. Inc. - June 16, 2021

Baum, W A Co. Inc., a medical device manufacturer in Copiague, NY, was inspected by the FDA from June 14-16, 2021. The inspection revealed a significant issue regarding the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the company lacked an electronic MDR procedure and an Electronic Submissions Gateway account for reporting serious injuries and deaths.