FDA 483 - MedisourceRx - June 10, 2025

The FDA conducted an inspection of MedisourceRx, an outsourcing facility located at 10525 Humbolt St, Los Alamitos, CA, from May 27 to June 10, 2025. The inspection revealed significant compliance issues under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations identified include the failure to report adverse drug experiences to the FDA as required by Section 503B(b)(5) of the FD&C Act and 21 CFR 310.305. Specifically, MedisourceRx did not report a serious adverse event involving a Semaglutide injection, which resulted in severe gastrointestinal issues and hospitalization, within the mandated 15-day period.

Additionally, the facility was found to have inadequate pest control measures. Inspectors observed a live spider in the production area where Active Pharmaceutical Ingredients (APIs) are stored, and a dead cricket in the incubator room used for environmental monitoring and media fill vials. These conditions suggest potential contamination risks, violating sanitary requirements.

MedisourceRx is required to address these violations promptly. The company must implement corrective actions to ensure timely reporting of adverse events and enhance pest control measures to maintain sanitary conditions in production areas. Failure to comply may result in further regulatory actions by the FDA. The company is encouraged to discuss objections or corrective actions with FDA representatives or submit additional information to the FDA for review.