FDA WARNING_LETTER - MedisourceRx - June 10, 2025

The FDA issued a Warning Letter to MedisourceRx following an inspection from May 27 to June 10, 2025, for significant violations related to its operations as an outsourcing facility. The company failed to meet conditions under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), primarily by not submitting a required adverse event report (Complaint Log # C25004) and possessing inadequate procedures for defining what constitutes a “serious” adverse event, as mandated by 21 CFR 310.305(b). These failures mean MedisourceRx"s compounded drug products do not qualify for regulatory exemptions typically afforded to outsourcing facilities.

Consequently, the drug products produced by MedisourceRx are deemed unapproved new drugs, misbranded due to lacking adequate directions for use, and in violation of specific adverse event reporting requirements. The company"s non-compliance subjects its drug products to new drug approval processes, comprehensive labeling requirements, and the Drug Supply Chain Security Act. Although some retroactive adverse event submissions were acknowledged, the FDA noted that current reporting procedures remain deficient.

MedisourceRx is required to take prompt corrective actions. The company must provide a written response within 15 working days, detailing specific steps taken to address these violations, measures to prevent their recurrence, and supporting documentation. Failure to adequately address these concerns may result in further legal enforcement actions by the FDA.