Drug factory · FDA FEI 3002808449
Lundbeck Pharmaceuticals Italy SpA
Viale dell'Industria 54, Padova, Italy
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Trimipramine | Makes the active ingredient | Breckenridge Pharmaceutical, Inc. | 51991-944, 51991-945, 51991-946 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 12, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 28, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 13, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.