Drug factory · FDA FEI 3003164454
Janssen Cilag SpA
Via C. Janssen, Borgo San Michele, Italy
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2024.
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
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 27, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 29, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 21, 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.
Sep 11, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis; label; manufacture; pack.