Drug factory · FDA FEI 3002653483
Novartis Pharma Stein AG
Schaffhauserstrasse, Stein, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Jul 19, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 4 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetylcholine | Makes it | Bausch & Lomb Incorporated | 24208-539 |
| Baclofen | Makes it | Medtronic Neuromodulation | 58281-560, 58281-561, 58281-562 +1 |
| Deferoxamine | Makes it, tests it and packages it | Mitem Pharma | 87081-467 |
| Tislelizumab | Makes it and tests it | BeOne Medicines USA, Inc. | 72579-121, 72579-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 9, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| May 1, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 25, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 22, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 2, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 2, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 9, 2017 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - Lot or control number assigned 21 CFR 211.130(c)
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems. Electronic records are used, but they do not meet retention requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Quarantine Storage of Components 21 CFR 211.82(b)
Incoming components and drug product containers are not stored under quarantine until they have been tested or examined, as appropriate, and released.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.