# FDA 483 - Xlear Inc. - March 18, 2022

Source: https://www.keypedia.com/records/483/xlear-inc/2c69d6a9-66db-4205-b040-d3048d09d6af

> FDA 483 for Xlear Inc. on March 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xlear Inc.
- Inspection Date: 2022-03-18
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Xlear Inc. in American Fork, UT, was inspected and cited for nine observations related to its manufacturing and quality control practices. The inspection revealed significant deficiencies across materials sampling, stability testing, laboratory controls, quality unit procedures, record keeping, production phase time limits, and labeling controls. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting drug product quality and purity.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.keypedia.com/companies/xlear-inc/5bebc43f-2435-4ce8-a5b8-551a98738f4a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face