Drug factory · FDA FEI 3002807485
Loba biotech GmbH
Fehrgasse 7, Fischamend, Austria
Problems found, fixed voluntarily at FDA's last inspection, Oct 13, 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 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Peginterferon Alfa-2a | Makes the active ingredient | pharmaand GmbH | 82154-0449, 82154-0451 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 17, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 24, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.