Drug factory · FDA FEI 3004715600
Ethypharm
Chemin de la Poudrière, Le Grand Quevilly, France
Problems found, fixed voluntarily at FDA's last inspection, Oct 7, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fenofibric Acid | Makes it | Lupin Pharmaceuticals, Inc. | 27437-109, 27437-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 7, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 5, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 19, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 19, 2009 | Problems found, fixed voluntarily | 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.
Oct 19, 2012 inspection
- Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products.
Registered with FDA for: analysis; manufacture.