FDA establishment 3003098680, Marburg, Germany. Part of CSL Behring's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Feb 18, 2026 | Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies; Biologics · Vaccines and Allergenic Products | 5 cited references
| Voluntary Action Indicated (VAI) |
| Mar 4, 2022 | Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| May 17, 2016 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Jan 27, 2012 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Mar 18, 2010 | Drugs · Drug Quality AssuranceBiologics · Vaccines and Allergenic Products; Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human…Device · Z-1790-2020 | Class II | Mar 2, 2020 |
| Antihemophilic Factor (Human)Biologic · B-0140-2020 | Class III | Oct 7, 2019 |
| Prothrombin Complex Concentrate (Human)Biologic · B-0653-2019 | Class III | Apr 5, 2019 |
| Prothrombin Complex Concentrate (Human)Biologic · B-0062-2019 | Class II | Jun 4, 2018 |
| N Latex CDT KitDevice · Z-2931-2018 | Class II | May 31, 2018 |
| Prothrombin Complex Concentrate (Human)Biologic · B-0061-2019 | Class II | Mar 22, 2018 |
| SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens…Device · Z-0190-2018 · 2 products | Class II | Jun 5, 2017 |
| Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro…Device · Z-2241-2016 | Class II | May 17, 2016 |
| Prothrombin Complex Concentrate (Human)Biologic · B-0566-16 | Class III | Mar 18, 2016 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports