Drug factory · FDA FEI 3002806860
Xellia Pharmaceuticals ApS
Dalslandsgade 11, Copenhagen S, Denmark
Problems found, fixed voluntarily at FDA's last inspection, Dec 4, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 0 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Vancomycin | Makes it, makes the active ingredient, tests it, packages it and labels it | BluePoint Laboratories., Civica, Inc., Fresenius Kabi, LLC, Samson Medical Technologies, L.L.C., Xellia Pharmaceuticals USA LLC, Xellia Pharmaceuticals, ApS | 68001-406, 68001-407, 72572-803 +12 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 4, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 11, 2010 | 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.
May 8, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.