Drug factory · FDA FEI 3002865753
Novartis Pharma Schweizerhalle AG
Rothausstrasse, Pratteln CH, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Mar 27, 2025.
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: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Panobinostat | Makes it and makes the active ingredient | Secura Bio, Inc. | 73116-100, 73116-101, 73116-102 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 27, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 25, 2022 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 14, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 25, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 9, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 10, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; particle size reduction.