FDA record · 503B outsourcing facility

Assure Infusions, Inc.: FDA 503B outsourcing facility record

Assure Infusions, Inc. in Bartow, FL is on FDA's register of 503B outsourcing facilities. Registered since Nov 22, 2024; last FDA inspection Sep 17, 2026; Form 483 issued at that inspection: Yes; action FDA lists: Open. Register updated by FDA Sep 30, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA register read Oct 3

Status: Registered since Nov 22, 2024; last FDA inspection Sep 17, 2026.

What FDA’s register states

FDA register entry for Assure Infusions, Inc.
Field	What FDA’s record states	Source
Facility	Assure Infusions, Inc.	FDA register
Location	Bartow, FL	FDA register
First registered	Nov 22, 2024	FDA register
Most recent registration	Dec 5, 2025	FDA register
Last FDA inspection	Sep 17, 2026	FDA register
Form 483 issued	Yes	FDA register
Recall conducted	No	FDA register
Action based on last inspection	Open	FDA register
Earlier compounding action	Not published by FDA	n/a
Intends to compound sterile drugs from bulk	No	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