Fresenius Kabi Compounding LLC dba Fagron Sterile Services
FDA 503B outsourcing facility
Canton, Massachusetts
Key Takeaways
- FDA-registered 503B outsourcing facility since 2017
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: November 5, 2025
- FDA action: Warning Letter Issued 5/12/2026
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 21, 2017
- Most recent registration
- November 22, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- November 5, 2025
The FDA last inspected Fresenius Kabi Compounding LLC dba Fagron Sterile Services on November 5, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Warning Letter Issued 5/12/2026.
Compounded peptides and GLP-1s
Fresenius Kabi Compounding LLC dba Fagron Sterile Services has not assigned NDCs or filed product reports in the most recent FDA reporting periods. 503B outsourcing facilities are a primary supply route for compounded peptides and GLP-1s during FDA-listed shortages; PeptideGrids grades the evidence for each, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the GLP-1 and therapeutic peptide databases.
Contact
FDA-registered contact: Deborah McHugh, 316-773-0405. 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 Fresenius Kabi Compounding LLC dba Fagron Sterile Services with the Massachusetts Board of Registration in Pharmacy.
503B facilities in Massachusetts
Frequently asked questions
Is Fresenius Kabi Compounding LLC dba Fagron Sterile Services registered with the FDA?
Yes. Fresenius Kabi Compounding LLC dba Fagron Sterile Services is a registered 503B outsourcing facility, first registered with the FDA on April 21, 2017 and most recently registered on November 22, 2025.
Has Fresenius Kabi Compounding LLC dba Fagron Sterile Services been inspected by the FDA?
The FDA last inspected Fresenius Kabi Compounding LLC dba Fagron Sterile Services on November 5, 2025. A Form FDA 483 was issued. FDA action on record: Warning Letter Issued 5/12/2026.
Has Fresenius Kabi Compounding LLC dba Fagron Sterile Services had any FDA drug recalls?
No FDA drug recalls are matched to Fresenius Kabi Compounding LLC dba Fagron Sterile Services in the openFDA enforcement database.
What does Fresenius Kabi Compounding LLC dba Fagron Sterile Services compound?
Fresenius Kabi Compounding LLC dba Fagron Sterile Services has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is Fresenius Kabi Compounding LLC dba Fagron Sterile Services located?
Fresenius Kabi Compounding LLC dba Fagron Sterile Services is located in Canton, Massachusetts.
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Fresenius Kabi Compounding LLC dba Fagron Sterile Services. 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.