ProRx LLC
ProRx LLC, a 503B outsourcing facility in Exton, PA, received an FDA Warning Letter following a September 2025 inspection that found the company compounding tirzepatide and semaglutide injectable products under insanitary conditions with serious sterility assurance failures. The facility violated section 503B by using tirzepatide bulk drug substance not on the 503B bulks list, omitting required label statements, and failing to maintain adequate adverse event reporting procedures. Multiple CGMP violations were cited including inadequate contamination investigations, blocked first air during aseptic operations, and use of non-sterilized equipment in ISO 5 areas. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure or injunction.
Flagged claims (6)
your facility's procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include an adequate definition of what constitutes a "serious" adverse event
your response claimed the study demonstrated that first air to the stoppers was maintained and there was no contamination risk from your operator forearms during the stoppering process in your ISO 5 area
Some of your facility's drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, Glutathione Injection 2000mg, and Tirzepatide Injection 45mg/2.5mL, did not include the following statement on the label: the statement "Not for Resale"
some of your facility's drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, did not contain the following on the label: the established name of the drug
your facility compounded (b)(4) vials of Tirzepatide 72MG/4ML injectable drug product and on (b)(4), your facility compounded (b)(4) vials of Tirzepatide 45MG/2.5ML injectable drug product, using tirzepatide bulk drug substance on both dates
your revised label for Nicotinamide Adenine Dinucleotide no longer includes a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient, as required by section 503B(a)(10)(iii)(X)
Required actions (4)
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 that, on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
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