Drug factory · FDA FEI 3002716636
Olon SpA
STRADA PROVINCIALE RIVOLTANA 6/7, Rodano, Italy
Problems found, fixed voluntarily at FDA's last inspection, Mar 28, 2025.
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 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levoketoconazole | Tests it | Xeris Pharmaceuticals, Inc. | 72065-003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 7, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.