Becker's Healthcare January 30, 2025
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, which registered as an outsourcing drug compounder in April 2022, was found to have violated several critical provisions under the Federal Food, Drug and Cosmetic Act.
FDA investigators visited ProRx from July 15 to Aug. 2, 2024, and identified multiple violations, including improper production practices and failure to meet sterility requirements for compounded drugs, such as semaglutide and tirzepatide.
Among the issues raised were failures to meet labeling and adverse-event reporting...
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