483
Bio-Med Devices, Inc.FDA 483 - Bio-Med Devices, Inc. - March 31, 2022
Record Details
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.
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ID · 93914fe9-3e97-49f6-bf5e-6fb2858ff28f