FDA record · 503B outsourcing facility

Fresenius Kabi Compounding LLC dba Fagron Sterile Services: FDA 503B outsourcing facility record

Fresenius Kabi Compounding LLC dba Fagron Sterile Services in Canton, MA is on FDA's register of 503B outsourcing facilities. Registered since Apr 21, 2017; last FDA inspection Nov 5, 2025; Form 483 issued at that inspection: Yes; action FDA lists: Warning Letter Issued 5/12/2026. Register updated by FDA Sep 30, 2026.

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Status: Registered since Apr 21, 2017; last FDA inspection Nov 5, 2025.

What FDA’s register states

FDA register entry for Fresenius Kabi Compounding LLC dba Fagron Sterile Services
Field	What FDA’s record states	Source
Facility	Fresenius Kabi Compounding LLC dba Fagron Sterile Services	FDA register
Location	Canton, MA	FDA register
First registered	Apr 21, 2017	FDA register
Most recent registration	Nov 22, 2025	FDA register
Last FDA inspection	Nov 5, 2025	FDA register
Form 483 issued	Yes	FDA register
Recall conducted	No	FDA register
Action based on last inspection	Warning Letter Issued 5/12/2026	FDA register
Earlier compounding action	Not published by FDA	n/a
Intends to compound sterile drugs from bulk	Yes	FDA 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.

Source

Copied from FDA’s Registered Outsourcing Facilities table ↗, updated by FDA Sep 30, 2026, read Oct 3, 2026. The table does not include State Board of Pharmacy actions. All 98 registered facilities