Drug factory · FDA FEI 3003157245
Delpharm Huningue
26 Rue de la Chapelle, Huningue, France
Problems found, fixed voluntarily at FDA's last inspection, Nov 30, 2023.
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 2011: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Perampanel | Makes it, tests it and packages it | Eisai Inc. | 62856-290 |
| Rufinamide | Makes it, tests it, packages it and labels it | Eisai Inc. | 62856-584 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 30, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 8, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 22, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 19, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 15, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 15, 2011 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: analysis; label; manufacture; pack.