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 standards, with products missing essential information such as “this is a compounded drug” and clear dosage instructions. Additionally, the facility did not submit adverse-event reports to the FDA, failing to comply with regulations designed to ensure drug safety.
In addition, investigators found several violations of current good manufacturing practices with concerns over insanitary conditions that could lead to contamination. This includes improper gowning procedures, lack of environmental monitoring and failures in aseptic technique.
ProRx has been given a 15-day deadline to resolve these issues or risk more severe consequences such as potential restrictions on its ability to compound and distribute drugs.
