ProRx, LLC
FDA issued an amended warning letter to ProRx, LLC, a 503B outsourcing facility in Exton, PA, following a July–August 2024 inspection that uncovered serious sterility assurance failures and CGMP violations in the production of sterile drug products including Semaglutide and Tirzepatide. The facility's compounded drugs were found to be adulterated due to insanitary conditions (e.g., insects in cleanrooms, improper gowning, no environmental monitoring in ISO 5 areas) and misbranded due to inadequate labeling and failure to meet 503B conditions. ProRx voluntarily recalled all sterile products within expiry on August 22, 2024, and ceased sterile production, but FDA found multiple corrective action responses deficient. FDA warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (4)
Semaglutide 5mg/2ml (2.5mg/ml) 2ml, Tirzepatide 60mg/3ml (20mg/ml) 3ml, and Vancomycin 25mg/ml 10ml, did not include the following on the label: the statement "This is a compounded drug"; the name, address, and phone number of the applicable outsourcing facility; the established name of the drug; the dosage form; the statement "Office Use Only"; and a list of active and inactive ingredients
You do not have any FDA-approved applications on file for drug products that you compound.
Vancomycin 25mg/ml 10ml, and Tobramycin 14mg/ml 10ml, did not include the following information on the container: 1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 and 2) directions for use, including, as appropriate, dosage and administration.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
Required actions (3)
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. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA also acknowledges your voluntary recall, on August 22, 2024, of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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