# FDA 483 - APEX Biologix, LLC - September 01, 2022

Source: https://www.keypedia.com/records/483/apex-biologix-llc/08c8ce96-5448-489d-b66a-faa6e6fd7f70

> FDA 483 for APEX Biologix, LLC on September 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APEX Biologix, LLC
- Inspection Date: 2022-09-01
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of APEX Biologix, LLC, a biological medical device manufacturer in Woods Cross, UT, revealed significant deficiencies in the firm's quality system. The inspection cited inadequate document control procedures, specifically concerning the review and approval of documents. Additionally, the firm's complaint handling procedures were found to be insufficiently established, leading to concerns about uniform and timely complaint processing.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/apex-biologix-llc/87e90f06-188c-48d5-b4cc-8ea4117f5769

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