PriceTracker GLP-1

FDA record · 503B outsourcing facility

ProRx LLC: FDA 503B outsourcing facility record

ProRx LLC in Exton, PA is on FDA's register of 503B outsourcing facilities. Registered since Apr 27, 2022; last FDA inspection Sep 19, 2025; Form 483 issued at that inspection: Yes; action FDA lists: Warning Letter Issued 4/7/2026. Register updated by FDA Sep 30, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA register read October 2026
Status: Registered since Apr 27, 2022; last FDA inspection Sep 19, 2025.

What FDA’s register states

FDA register entry for ProRx LLC
FieldWhat FDA’s record statesSource
FacilityProRx LLCFDA register
LocationExton, PAFDA register
First registeredApr 27, 2022FDA register
Most recent registrationFeb 20, 2026FDA register
Last FDA inspectionSep 19, 2025FDA register
Form 483 issuedYesFDA register
Recall conductedNoFDA register
Action based on last inspectionWarning Letter Issued 4/7/2026FDA register
Earlier compounding actionNot published by FDAn/a
Intends to compound sterile drugs from bulkYesFDA register

Registration is a filing, not an approval.A Form FDA 483 lists what investigators observed; in FDA’s words it “does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations.” “Open” means FDA has not determined whether further action will be taken.

GLP-1 warning letters to a firm of this name

ProRx LLCApr 7, 2026ProRx, LLCMar 4, 2025

Matched by name; FDA’s letter gives the address it was sent to.

GLP-1 recalls by a firm of this name

  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0114-2026 · Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffe...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0115-2026 · Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0116-2026 · Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Je...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0117-2026 · Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Je...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0118-2026 · Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0119-2026 · Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff...
  • Class II, ongoing, reported Nov 5, 2025Lack of Assurance of SterilityD-0120-2026 · Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffe...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0650-2024 · Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-0...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0651-2024 · Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, N...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0652-2024 · SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341,...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0653-2024 · SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0654-2024 · Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-70...
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0655-2024 · TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
  • Class II, ongoing, reported Sep 11, 2024Lack of Assurance of SterilityD-0656-2024 · TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02

Matched by name, from FDA’s enforcement reports (updated by FDA Sep 30, 2026). Every GLP-1 recall

Source

Copied from FDA’s Registered Outsourcing Facilities table ↗, updated by FDA Sep 30, 2026, read Oct 7, 2026. The table does not include State Board of Pharmacy actions. All 98 registered facilities