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

Source: https://www.globalkeysolutions.net/records/483/bio-med-devices-inc/93914fe9-3e97-49f6-bf5e-6fb2858ff28f

> FDA 483 for Bio-Med Devices, Inc. on March 31, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Med Devices, Inc.
- Inspection Date: 2022-03-31
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Officers

- [Eric C. Schmitt](https://www.globalkeysolutions.net/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.globalkeysolutions.net/companies/bio-med-devices-inc/39493c09-314b-444a-9c89-2dae1ee10bc9

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7