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# Court Enters Consent Decree Against Oklahoma Compounder
- URL: https://www.fdaweb.com/court-enters-consent-decree-against-oklahoma-compounder/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153446

An Oklahoma federal court has entered a consent decree against Qualgen, a drug outsourcing facility that FDA says has a “history of violations.” An agency [statement](https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-oklahoma-drug-compounder?ref=fdaweb.com) says the decree prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce.

The consent decree was entered against Qualgen, its majority owner, **Shaun Riney**, and its director of quality, **Jasen Lavoie**, in response to an FDA complaint asserting that the company introduced into interstate commerce adulterated drugs that were manufactured, processed, packed, or held under conditions that violated current good manufacturing practice (CGMP) requirements, FDA says.

The statement says the agency inspected and cited Qualgen for violations of CGMP requirements during several inspections since 2015, issuing a safety alert in 2015 and a Warning Letter in 2016\. The most recent inspection of the company’s Oklahoma facilities ended in 9/2022, it says.