Orion Specialty Labs
FDA 503B outsourcing facility
LLC
Key Takeaways
- FDA-registered 503B outsourcing facility since 2025
- Sterile compounding from bulk substances: Yes
- Not yet inspected by the FDA
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
- September 19, 2025
- Most recent registration
- February 24, 2026
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- Not yet inspected
Orion Specialty Labs has registered with the FDA as a 503B outsourcing facility but has not yet been inspected. The FDA inspects registered facilities on a risk-based schedule once drug production and distribution are confirmed.
Compounded peptides and GLP-1s
Orion Specialty Labs 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: Kimberly Mattera, 1-917-414-2469. Source: the facility's FDA outsourcing registration.
Frequently asked questions
Is Orion Specialty Labs registered with the FDA?
Yes. Orion Specialty Labs is a registered 503B outsourcing facility, first registered with the FDA on September 19, 2025 and most recently registered on February 24, 2026.
Has Orion Specialty Labs been inspected by the FDA?
Orion Specialty Labs has registered with the FDA but has not yet been inspected as a 503B outsourcing facility.
Has Orion Specialty Labs had any FDA drug recalls?
No FDA drug recalls are matched to Orion Specialty Labs in the openFDA enforcement database.
What does Orion Specialty Labs compound?
Orion Specialty Labs has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is Orion Specialty Labs located?
Orion Specialty Labs is located in LLC.
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 Orion Specialty Labs. 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.