Drug factory · FDA FEI 3001624853
Dipharma Francis Srl
Via Bissone 5, Baranzate, Italy
Problems found, fixed voluntarily at FDA's last inspection, Jul 15, 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: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupropion and Dextromethorphan | Makes the active ingredient | Axsome Therapeutics, Inc. | 81968-030, 81968-045, 81968-345 +1 |
| Cyclobenzaprine | Makes the active ingredient | Amneal Pharmaceuticals | 0115-1436, 0115-1437 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 15, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2012 | No problems found | Drug Quality Assurance | — |
| May 15, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.