Qualgen LLC
FDA 503B outsourcing facility
Edmond, Oklahoma
Key Takeaways
- FDA-registered 503B outsourcing facility since 2015
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: September 4, 2025
- 27 FDA drug recalls on record (2015 to 2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- May 23, 2015
- Most recent registration
- December 17, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- September 4, 2025
The FDA last inspected Qualgen LLC on September 4, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
Qualgen LLC has 27 FDA drug recalls on record between 2015 and 2025, based on the FDA enforcement database. Breakdown: 24 Class II, 3 Class III.
Recall reasons on record include labeling: incorrect or missing lot and/or exp. date: a printing issue resulted in; lack of assurance of sterility; labeling: incorrect or missing lot and/or exp date; cgmp deviations- lack of quality assurance; lack of assurance of sterility: the firm is recalling all sterile preparations within.
| Date | Class | Product | Reason |
|---|---|---|---|
| June 2025 | Class III | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69 | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. |
| October 2018 | Class II | Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility |
| October 2018 | Class II | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-3 | Lack of Assurance of Sterility |
| October 2018 | Class II | Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) | Lack of Assurance of Sterility |
| October 2018 | Class II | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30 | Lack of Assurance of Sterility |
Showing the 5 most recent of 27 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Qualgen LLC reports compounding 3 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Anastrozole; Testosterone
- Estradiol
- Testosterone
Location
14844 Bristol Park Blvd, N/A, Edmond, OK 73013-1891
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Shaun Riney, 405-463-4141. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Qualgen LLC with the Oklahoma State Board of Pharmacy.
503B facilities in Oklahoma
Oklahoma has 2 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Oklahoma.
Frequently asked questions
Is Qualgen LLC registered with the FDA?
Yes. Qualgen LLC is a registered 503B outsourcing facility, first registered with the FDA on May 23, 2015 and most recently registered on December 17, 2025.
Has Qualgen LLC been inspected by the FDA?
The FDA last inspected Qualgen LLC on September 4, 2025. A Form FDA 483 was issued.
Has Qualgen LLC had any FDA drug recalls?
Qualgen LLC has 27 FDA drug recalls on record (2015 to 2025) in the FDA enforcement database.
What does Qualgen LLC compound?
Qualgen LLC reports compounding 3 active ingredients to the FDA.
Where is Qualgen LLC located?
Qualgen LLC is located in Edmond, Oklahoma (14844 Bristol Park Blvd).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Qualgen LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.