Drug factory · FDA FEI 3003015552
Isomedix Operations Inc
2500 Commerce Dr, Libertyville, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Risperidone | Sterilizes it | Indivior Inc. | 12496-0090, 12496-0120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 28, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 24, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 2, 2009 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 3, 2015 inspection
- Production processes 21 CFR 820.70(a)
Production processes were not conducted to ensure that a device conforms to its specifications.
Registered with FDA for: sterilize.