FDA record · 503B outsourcing facility

Denver Solutions, LLC, dba Leiters Health: FDA 503B outsourcing facility record

Denver Solutions, LLC, dba Leiters Health in Englewood, CO is on FDA's register of 503B outsourcing facilities. Registered since Mar 24, 2017; last FDA inspection Dec 11, 2025; Form 483 issued at that inspection: Yes; action FDA lists: Untitled Letter Issued 6/8/2026. Register updated by FDA Sep 30, 2026.

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

Status: Registered since Mar 24, 2017; last FDA inspection Dec 11, 2025.

What FDA’s register states

FDA register entry for Denver Solutions, LLC, dba Leiters Health
Field	What FDA’s record states	Source
Facility	Denver Solutions, LLC, dba Leiters Health	FDA register
Location	Englewood, CO	FDA register
First registered	Mar 24, 2017	FDA register
Most recent registration	Nov 28, 2025	FDA register
Last FDA inspection	Dec 11, 2025	FDA register
Form 483 issued	Yes	FDA register
Recall conducted	No	FDA register
Action based on last inspection	Untitled Letter Issued 6/8/2026	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