Drug factory · FDA FEI 2183744
Isomedix Operations Inc.
380 90th Ave Nw, Minneapolis, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 15, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gemcitabine | Sterilizes it | Janssen Biotech, Inc. | 57894-225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: sterilize.