# FDA 483 - Breas Medical, Inc. - January 18, 2022

Source: https://www.keypedia.com/records/483/breas-medical-inc/20517386-6045-4782-9be4-c6feb348d276

> FDA 483 for Breas Medical, Inc. on January 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Breas Medical, Inc.
- Inspection Date: 2022-01-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Breas Medical, Inc., a manufacturer of ventilator products in North Billerica, MA, identified one observation. The firm was cited for not adequately establishing procedures to control environmental conditions, specifically regarding electrostatic discharge (ESD) or electrical overstress (EOS) for powered tools used in servicing ventilator products. This indicates a deficiency in their quality system for environmental controls.

## Related Documents

- [483 - 2020-02-06](https://www.keypedia.com/records/483/breas-medical-inc/546afc3f-ccac-40b6-9fa4-232ad47a63e5)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/breas-medical-inc/203fa837-ecb2-44c2-91d8-073b586f2670

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94