Orion Specialty Labs, LLC
Orion Specialty Labs, LLC is a registered 503B outsourcing facility. When the FDA last inspected it, what it found, and what that means for a compounded prescription.
By Sam Reed · Founder and data lead
Registered, but never inspected
Registering as an outsourcing facility is a filing, not an approval. The FDA has not yet inspected this one, so there is no inspection record to read either way.
Orion Specialty Labs, LLC is registered with the FDA as a 503B outsourcing facility. A 503B may compound medication in bulk without a prescription for a named patient, and it is inspected against manufacturing standards — which a 503A compounding pharmacy is not.
The register
Its FDA record
| Check | What the register shows | Source |
|---|---|---|
| Registered since | Sep 19, 2025 | FDA register |
| Registration renewed | Feb 24, 2026 | FDA register |
| Last FDA inspection | Not yet inspected | FDA register |
| Form 483 issued | Not applicable — never inspected | FDA register |
| Recall conducted | Not applicable — never inspected | FDA register |
| Action from last inspection | None on record | FDA register |
| Compounds sterile drugs from bulk | Yes | Facility registration |
Data sources · cited with retrieval dates
- FDA warning lettersPublished compliance actions, updated weekly
- FDA registered outsourcing facilities503B register, with inspection and enforcement status
- FDA National Drug Code directoryLabeler, product and package listings
NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.