Drug factory · FDA FEI 1220477
Isomedix Operations Inc
435 Whitney Street, Northborough, MA, United States
No problems found at FDA's last inspection, Aug 1, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2013: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dexamethasone | Sterilizes it | Ocular Therapeutix, Inc. | 70382-204 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 1, 2025 | No problems found | Drug Quality Assurance | — |
| Mar 9, 2020 | No problems found | Drug Quality Assurance | — |
| Jan 21, 2015 | No problems found | Drug Quality Assurance | — |
| Jan 4, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: sterilize.