Drug factory · FDA FEI 3004594563
Eurofins BioPharma Product Testing Leiden B.V.
Darwinweg 24, Leiden, Netherlands
Problems found, fixed voluntarily at FDA's last inspection, Jul 1, 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 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Erythropoietin | Tests it | Pfizer Laboratories Div Pfizer Inc | 0069-1305, 0069-1306, 0069-1307 +4 |
| Motixafortide | Tests it | BioLineRx USA Inc | 82737-073 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 21, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2011 | 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.
Sep 7, 2017 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis.