Hikma Injectables USA Inc.
Hikma Injectables USA Inc. of Dayton, NJ 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
FDA action on record: Open
The register records this against the facility’s most recent inspection. It is a fact about the compounder, not about any one prescription it has filled.
Hikma Injectables USA Inc. of Dayton, New Jersey 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 15, 2021 | FDA register |
| Registration renewed | Dec 29, 2025 | FDA register |
| Last FDA inspection | Aug 8, 2025 | FDA register |
| Form 483 issued | Yes — read the 483 | FDA register |
| Recall conducted | No | FDA register |
| Action from last inspection | Open | FDA register |
| Compounds sterile drugs from bulk | No | 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.