# FDA 483 - Breas Medical, Inc. - February 06, 2020

Source: https://www.keypedia.com/records/483/breas-medical-inc/546afc3f-ccac-40b6-9fa4-232ad47a63e5

> FDA 483 for Breas Medical, Inc. on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Breas Medical, Inc.
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Breas Medical, Inc. in North Billerica, MA was inspected from February 4-6, 2020, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's complaint handling procedures, leading to significant delays in complaint closure. Additionally, the firm failed to adequately maintain device history records, specifically lacking primary identification labels and other required device identifiers for production units.

## Related Documents

- [483 - 2022-01-18](https://www.keypedia.com/records/483/breas-medical-inc/20517386-6045-4782-9be4-c6feb348d276)

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)
- [Crystal Nevins](https://www.keypedia.com/people/crystal-nevins/c004def9-c46e-4a9e-be39-742bcc27e90e)

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