# FDA 483 - Qualgen, LLC - September 04, 2025

Source: https://www.globalkeysolutions.net/records/483/qualgen-llc/ac33b67e-f358-415b-b324-fbf18a268ca5

> FDA 483 for Qualgen, LLC on September 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qualgen, LLC
- Inspection Date: 2025-09-04
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Qualgen, LLC in Edmond, OK, was inspected and received a Form 483 with five observations, including repeat findings. The inspection revealed significant deficiencies in cross-contamination prevention, quality control unit adherence to procedures, environmental controls, and sterile product manufacturing processes. These issues indicate a systemic failure to ensure drug product quality, identity, strength, and purity.

## Related Documents

- [483 - 2015-09-17](https://www.globalkeysolutions.net/records/483/qualgen-llc/eb552b36-1af9-49ed-b518-23d439cb5bed)
- [483 - 2017-05-10](https://www.globalkeysolutions.net/records/483/qualgen-llc/72a3330a-d0fc-407b-833b-89ceab73a122)
- [483 - 2022-09-30](https://www.globalkeysolutions.net/records/483/qualgen-llc/e9406a07-eaa7-4aa0-aaf4-236f90b0bc0c)
- [483 - 2024-03-19](https://www.globalkeysolutions.net/records/483/qualgen-llc/c3c18736-2028-4771-9538-1dd4b0b50e83)
- [483 - 2025-08-19](https://www.globalkeysolutions.net/records/483/qualgen-llc/7764f418-76a6-42b3-9cc7-ed20bd6671e9)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Pharmaceutical Program Expert](https://www.globalkeysolutions.net/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.globalkeysolutions.net/companies/qualgen-llc/62f55b89-23e3-4f94-a760-91a6c5f071c7

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9