FDA record · 503B outsourcing facility

McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions: FDA 503B outsourcing facility record

McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions in Santa Ana, CA is on FDA's register of 503B outsourcing facilities. Registered since Jan 11, 2023; not yet inspected by FDA. Register updated by FDA Sep 30, 2026.

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

Status: Registered since Jan 11, 2023; not yet inspected by FDA.

What FDA’s register states

FDA register entry for McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions
Field	What FDA’s record states	Source
Facility	McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions	FDA register
Location	Santa Ana, CA	FDA register
First registered	Jan 11, 2023	FDA register
Most recent registration	Dec 2, 2025	FDA register
Last FDA inspection	Not yet inspected	FDA register
Form 483 issued	Not published by FDA	FDA register
Recall conducted	Not published by FDA	FDA register
Action based on last inspection	Not published by FDA	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