Drug factory · FDA FEI 3002807647
Mipharm Spa
VIA BERNARDO QUARANTA 12, Milano, Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 29, 2024.
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 2011: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Diclofenac | Makes it | Leading Pharma, LLC | 69315-506 |
| Dihydroergotamine | Makes it, tests it, packages it and labels it | Advagen Pharma Ltd., Cipla USA., Inc., Exelan Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Oceanside Pharmaceuticals., Somerset Therapeutics, LLC | 72888-096, 69097-503, 76282-680 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 22, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 17, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 10, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.