FDA 483 - Bio-Med Devices, Inc. - March 31, 2022

An FDA inspection of Bio-Med Devices, Inc. in Guilford, CT, revealed two significant observations regarding their manufacturing practices. The firm failed to adequately establish procedures for product handling, specifically concerning electrostatic-discharge (ESD) protective measures during ventilator assembly. Additionally, non-conforming products were not adequately controlled, as evidenced by a lack of retest documentation for a ventilator that sparked during initial power-up.