Drug factory · FDA FEI 3002807252
Merck Serono Spa
VIA LUIGI EINAUDI 11, Guidonia Montecelio, Italy
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 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 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pegfilgrastim | Tests it | Fresenius Kabi USA, LLC, Northstar Rx LLC. | 65219-371, 72603-402 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 28, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 20, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 14, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 1, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 30, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.