Drug factory · FDA FEI 3008138971
Cenexi
17 RUE DE PONTOISE, Osny, France
Problems found, fixed voluntarily at FDA's last inspection, Dec 14, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2010: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tiratricol | Makes it | Rare Thyroid Therapeutics International AB | 87216-0100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 14, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 7, 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.
May 13, 2016 inspection
- Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
Registered with FDA for: analysis; label; manufacture; pack.