FDA 483 - W.A. Baum Co. Inc. - November 06, 2023

An FDA inspection of W.A. Baum Co. Inc., a medical device manufacturer in Copiague, NY, identified three significant observations. The firm failed to maintain adequate written procedures for Medical Device Reporting (MDR) and did not establish sufficient requirements for suppliers. Additionally, corrective and preventive action activities, specifically rework documentation, were found to be inadequate.