Drug factory · FDA FEI 3002037047
Novartis Manufacturing NV
Rijksweg 14, Puurs-Sint-Amands, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Mar 5, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Balanced Salt Solution | Makes it | Alcon Laboratories, Inc. | 0065-0795 |
| Brimonidine and Brinzolamide | Makes it | Alcon Laboratories, Inc. | 0065-4147 |
| Dexamethasone and Neomycin and Polymyxin B | Makes it | Nordic Pharma, Inc. | 69918-515 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 5, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 29, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 26, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2010 | 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.
Nov 15, 2016 inspection
- 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 followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Registered with FDA for: label; manufacture; pack.