Drug factory · FDA FEI 1416120
Esteve CDMO US, Inc. dba Regis Chemical Company
8210 Austin Avenue, Morton Grove, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 16, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levoketoconazole | Makes the active ingredient | Xeris Pharmaceuticals, Inc. | 72065-003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 23, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 15, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 17, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 30, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.