# Qualgen, LLC - Inspection Records

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

> Inspection records and compliance data for Qualgen, LLC in Edmond, Oklahoma. Access full analysis and detailed observations.

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## Details

- Name: Qualgen, LLC
- FEI Number: 3011286349
- City: Edmond
- State: Oklahoma
- Country Name: United States
- Address Line 1: 14844 Bristol Park Blvd
- Zip Code: 73013
- Facility Type: Producer of Sterile Drugs

## Related Documents

- [483 - Qualgen, LLC - 2025-09-04](https://www.keypedia.com/records/483/qualgen-llc/ac33b67e-f358-415b-b324-fbf18a268ca5) — source: FDA, date: September 4, 2025
- [FDA Inspection 1281118 - Qualgen, LLC - 2025-09-04](https://www.keypedia.com/records/fda_inspections/qualgen-llc/3723c406-dcfc-4677-9d7f-fce96cf00e62) — source: FDA, date: September 4, 2025
- [483 - Qualgen, LLC - 2025-08-19](https://www.keypedia.com/records/483/qualgen-llc/7764f418-76a6-42b3-9cc7-ed20bd6671e9) — source: FDA, date: August 19, 2025
- [483 - Qualgen, LLC - 2024-03-19](https://www.keypedia.com/records/483/qualgen-llc/c3c18736-2028-4771-9538-1dd4b0b50e83) — source: FDA, date: March 19, 2024
- [FDA Inspection 1230061 - Qualgen, LLC - 2024-03-19](https://www.keypedia.com/records/fda_inspections/qualgen-llc/f01e24e0-97ba-4bda-b157-eb32b3b67475) — classification: Voluntary Action Indicated (VAI), source: FDA, date: March 19, 2024
- [483 - Qualgen, LLC - 2022-09-30](https://www.keypedia.com/records/483/qualgen-llc/e9406a07-eaa7-4aa0-aaf4-236f90b0bc0c) — source: FDA, date: September 30, 2022
- [FDA Inspection 1180879 - Qualgen, LLC - 2022-09-30](https://www.keypedia.com/records/fda_inspections/qualgen-llc/1607a77e-ce47-47f2-b91f-027fc6218939) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 30, 2022
- [FDA Inspection 1144481 - Qualgen, LLC - 2021-06-15](https://www.keypedia.com/records/fda_inspections/qualgen-llc/363737bd-4775-40ef-ba5f-324aea5008c5) — classification: Official Action Indicated (OAI), source: FDA, date: June 15, 2021
- [FDA Inspection 1067476 - Qualgen, LLC - 2018-09-13](https://www.keypedia.com/records/fda_inspections/qualgen-llc/7e376fe6-7283-46ea-8b08-11e0ad2fe928) — classification: Official Action Indicated (OAI), source: FDA, date: September 13, 2018
- [483 - Qualgen, LLC - 2017-05-10](https://www.keypedia.com/records/483/qualgen-llc/72a3330a-d0fc-407b-833b-89ceab73a122) — source: FDA, date: May 10, 2017
- [FDA Inspection 1014041 - Qualgen, LLC - 2017-05-10](https://www.keypedia.com/records/fda_inspections/qualgen-llc/d20201b1-e87c-4395-a9f4-078f8d6dd9aa) — classification: Official Action Indicated (OAI), source: FDA, date: May 10, 2017
- [483 - Qualgen, LLC - 2015-09-17](https://www.keypedia.com/records/483/qualgen-llc/eb552b36-1af9-49ed-b518-23d439cb5bed) — source: FDA, date: September 17, 2015
- [FDA Inspection 945189 - Qualgen, LLC - 2015-09-17](https://www.keypedia.com/records/fda_inspections/qualgen-llc/bb26dc8a-ea21-4792-96d3-54743708c4e0) — classification: Official Action Indicated (OAI), source: FDA, date: September 17, 2015

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## Related Officers

- [Development Coordinator](https://www.keypedia.com/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)