ProRx LLC
FDA 503B outsourcing facility
Exton, Pennsylvania
Key Takeaways
- FDA-registered 503B outsourcing facility since 2022
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: September 19, 2025
- FDA action: Warning Letter Issued 4/7/2026
- 14 FDA drug recalls on record (2024 to 2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- April 27, 2022
- Most recent registration
- February 20, 2026
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- September 19, 2025
The FDA last inspected ProRx LLC on September 19, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Warning Letter Issued 4/7/2026.
FDA recall history
ProRx LLC has 14 FDA drug recalls on record between 2024 and 2025, based on the FDA enforcement database. Breakdown: 14 Class II.
Recall reasons on record include lack of assurance of sterility.
| Date | Class | Product | Reason |
|---|---|---|---|
| October 2025 | Class II | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA | Lack of Assurance of Sterility |
| October 2025 | Class II | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA | Lack of Assurance of Sterility |
| October 2025 | Class II | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 1 | Lack of Assurance of Sterility |
| October 2025 | Class II | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA | Lack of Assurance of Sterility |
| October 2025 | Class II | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19 | Lack of Assurance of Sterility |
Showing the 5 most recent of 14 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
ProRx LLC reports compounding 21 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Glutathione, Gonadorelin, Liraglutide, NAD+, Semaglutide, Sermorelin, Tirzepatide.
- Cyanocobalamin
- Edetate Disodium
- Glutathione
- Gonadorelin
- Gonadorelin Acetate
- Inositol; Methionine; Choline Chloride
- Inositol; Methionine; Choline Chloride; Cyanocobalamin
- Inositol; Methionine; Choline Chloride; Methylcobalamin; Pyridoxine
- Lidocaine Hydrochloride; Oxymetazoline Hydrochloride
- Liraglutide
- Nadide
- Naltrexone
- Nicotinamide Adenine Dinucleotide
- Papaverine Hydrochloride; Alprostadil; Phentolamine Mesylate
- Phenylephrine Hydrochloride
- Semaglutide
- Sermorelin
- Sermorelin Acetate
- Tirzepatide
- Tobramycin Sulfate
- Vancomycin Hydrochloride
Location
619 Jeffers Cir, N/A, Exton, PA 19341-2540
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Contact
FDA-registered contact: Mark L'Hommedieu, 1-904-616-7355. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of ProRx LLC with the Pennsylvania State Board of Pharmacy.
503B facilities in Pennsylvania
Pennsylvania has 5 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Pennsylvania.
Frequently asked questions
Is ProRx LLC registered with the FDA?
Yes. ProRx LLC is a registered 503B outsourcing facility, first registered with the FDA on April 27, 2022 and most recently registered on February 20, 2026.
Has ProRx LLC been inspected by the FDA?
The FDA last inspected ProRx LLC on September 19, 2025. A Form FDA 483 was issued. FDA action on record: Warning Letter Issued 4/7/2026.
Has ProRx LLC had any FDA drug recalls?
ProRx LLC has 14 FDA drug recalls on record (2024 to 2025) in the FDA enforcement database.
What does ProRx LLC compound?
ProRx LLC reports compounding 21 active ingredients to the FDA, including Glutathione, Gonadorelin, Liraglutide, NAD+, Semaglutide, Sermorelin, Tirzepatide.
Where is ProRx LLC located?
ProRx LLC is located in Exton, Pennsylvania (619 Jeffers Cir).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by ProRx LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.