# FDA 483 - Qualgen, LLC - August 19, 2025

Source: https://www.keypedia.com/records/483/qualgen-llc/7764f418-76a6-42b3-9cc7-ed20bd6671e9

> FDA 483 for Qualgen, LLC on August 19, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Qualgen, LLC
- Inspection Date: 2025-08-19
- Product Type: drugs
- Office Name: Division of Southwest Imports
- Summary: An FDA inspection conducted at Qualgen, LLC, an outsourcing facility in Edmond, OK, from August 19, 2025, to September 4, 2025, identified significant deviations from established Good Manufacturing Practices. The primary observations included inadequate controls to prevent cross-contamination and widespread failures within the company"s quality control unit.

Specifically, the inspection noted insufficient physical and spatial separation during the manufacturing of hazardous drugs like testosterone and estradiol pellets. Shared anterooms lacked proper cleaning between different product runs, and the effectiveness of cleaning agents and procedures for deactivating hazardous drug residues was not documented. Furthermore, critical equipment used in hazardous drug production was not cleaned according to the company"s own procedures.

A repeat observation highlighted systemic failures within Qualgen"s quality control unit to consistently follow written procedures. This encompassed inaccurate and non-contemporaneous documentation of cleaning activities, deviations from established post-production vial inspection times and signatory requirements, and improper calibration of critical manufacturing equipment such as digital calipers and balances. The firm also failed to investigate and follow up on customer complaints regarding product quality and potential adverse events. Additionally, work instructions for potency testing of Active Pharmaceutical Ingredients were not fully followed, including incorrect preparation of reference standard calibration curves.

Qualgen, LLC is required to implement comprehensive corrective and preventive actions to address these deficiencies, ensuring compliance with regulatory standards and safeguarding the quality and purity of its drug products.

## Related Documents

- [483 - 2015-09-17](https://www.keypedia.com/records/483/qualgen-llc/eb552b36-1af9-49ed-b518-23d439cb5bed)
- [483 - 2017-05-10](https://www.keypedia.com/records/483/qualgen-llc/72a3330a-d0fc-407b-833b-89ceab73a122)
- [483 - 2022-09-30](https://www.keypedia.com/records/483/qualgen-llc/e9406a07-eaa7-4aa0-aaf4-236f90b0bc0c)
- [483 - 2024-03-19](https://www.keypedia.com/records/483/qualgen-llc/c3c18736-2028-4771-9538-1dd4b0b50e83)
- [483 - 2025-09-04](https://www.keypedia.com/records/483/qualgen-llc/ac33b67e-f358-415b-b324-fbf18a268ca5)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a