# FDA 483 - Breathe E-Z Systems, Inc. - July 17, 2019

Source: https://www.globalkeysolutions.net/records/483/breathe-e-z-systems-inc/9aacf992-833f-4b7b-b1cc-6e5176a0ec4a

> FDA 483 for Breathe E-Z Systems, Inc. on July 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Breathe E-Z Systems, Inc.
- Inspection Date: 2019-07-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Breathe E-Z Systems, Inc., a manufacturer of Class II CO Sleuth Carbon Monoxide Analyzers, revealed significant deficiencies in their quality system. The firm failed to establish procedures for device history records, acceptance activities for materials and devices, and the proper handling and documentation of customer complaints. These issues indicate a lack of fundamental controls over manufacturing processes and post-market surveillance.

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/breathe-e-z-systems-inc/1e53cae8-29f4-4357-a67e-7c4c6e508252

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8