# FDA 483 - Clariance Inc - June 04, 2019

Source: https://www.globalkeysolutions.net/records/483/clariance-inc/98535193-f891-4c51-aaec-926efcaaca64

> FDA 483 for Clariance Inc on June 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clariance Inc
- Inspection Date: 2019-06-04
- Product Type: device
- Office Name: Chicago District Office
- Summary: Clariance Inc., a medical device manufacturer and importer in Chicago, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately manage medical device reporting, complaint handling, corrective and preventive actions, and document control. These issues indicate a systemic failure to comply with regulatory requirements for post-market surveillance and quality processes.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)
- [Natasha R. Johnson](https://www.globalkeysolutions.net/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.globalkeysolutions.net/companies/clariance-inc/c3508c94-08ec-470f-8c29-c60291a76771

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669