Drug factory · FDA FEI 3007272813
Baccinex SA
Rue de la Source 3, Courroux, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Jun 7, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2022: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cysteamine | Makes it | Recordati Rare Diseases, Inc. | 55292-410 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 7, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 28, 2022 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. - Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete instructions and special notations. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into do not include the conclusions and follow-up. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use.
Registered with FDA for: manufacture.