MedisourceRx
FDA issued a warning letter to MedisourceRx, a 503B outsourcing facility in Los Alamitos, CA, following a May–June 2025 inspection that found the facility failed to meet section 503B conditions, primarily by not submitting required adverse event reports and maintaining inadequate adverse event reporting procedures. Because these conditions were not met, MedisourceRx's compounded drug products lost eligibility for exemptions from FDA approval requirements, rendering them unapproved new drugs and misbranded products under the FDCA. FDA found the facility's corrective responses partially deficient, noting that submitted procedures still did not adequately define 'serious' adverse events consistent with 21 CFR 310.305(b). The letter warns that continued non-compliance may result in seizure or injunction, and requires a written response within 15 working days.
Flagged claims (2)
You failed to submit the adverse event report identified in Complaint Log # C25004.
Your documented procedures for reporting adverse events do not adequately define what constitutes a "serious" adverse event (21 CFR 310.305(b)).
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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