FDA Issues Warning Letter to Hims & Hers Compounder
The Food and Drug Administration (FDA) recently issued a formal warning letter to MedisourceRx, which is a compounding pharmacy owned by Hims & Hers. This action follows a troubling inspection of the facility that identified serious issues.
Inspection Findings and Violations
The FDA inspection took place between May and June at the company’s location in Los Alamitos, California. During this inspection, the agency found significant violations, one of which was particularly concerning.
- MedisourceRx failed to report a serious adverse event involving a patient.
- The incident occurred in January 2025 when a patient experienced severe stomach problems.
- The patient required a three-night hospitalization after using a compounded version of semaglutide, a drug related to the popular weight loss medication Wegovy.
According to the FDA, the pharmacy did not notify the agency of this adverse event within the mandated 15-day period after learning about it. This breach of protocol raises questions about the company’s adherence to safety regulations.
Background on Hims & Hers and MedisourceRx
Hims & Hers acquired MedisourceRx in September 2024. The company has positioned itself in the healthcare market by focusing on telehealth and innovative solutions. However, this warning letter may impact its reputation and operations.
Implications for the Future
The warning from the FDA underscores the critical importance of compliance with reporting regulations in the pharmaceutical industry. Hims & Hers will need to address these issues promptly to ensure patient safety and regain regulatory trust.
As they move forward, the company will likely focus on improving oversight and communication related to its compounding pharmacy operations to prevent future violations.
