CSL Behring GmbH FDA Record
- Latest inspection VAI · Feb 18, 2026
- Last warning letter 2025
CSL Behring GmbH has 5 FDA recalls, 27 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to CSL Behring GmbH, the most recent on Sep 9, 2025. FDA has published 3 Form 483s for CSL Behring GmbH.
- Latest recall
- Z-1790-2020 · Class II · Mar 2, 2020
- Latest inspection
- Feb 18, 2026 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 27 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
CSL Behring GmbH: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 1 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 1 | 0 |
| 2017 | 2 | 0 | 0 | 2 | 0 |
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CSL Behring GmbH FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 9, 2025 · Letter on fda.gov | Advertising & Promotional Labeling/Drugs/Biological Products | Center for Biologics Evaluation and Research (CBER) | May 21, 2026 |
CSL Behring GmbH Form 483s
| Date | Document | FEI |
|---|---|---|
| Feb 18, 2026 · Document on fda.gov | 483 | 3003098680 |
| Apr 18, 2024 · Document on fda.gov | 483 | 3003098680 |
| Apr 18, 2024 · Document on fda.gov | 483 | 3003098680 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1790-2020 | Class II | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT)… | Mar 2, 2020 |
| Z-2931-2018 | Class II | N Latex CDT Kit | May 31, 2018 |
| Z-0190-2018 | Class II | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13… | Jun 5, 2017 |
| Z-0191-2018 | Class II | SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L… | Jun 5, 2017 |
| Z-2241-2016 | Class II | Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in… | May 17, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 18, 2026 | Marburg, Germany | Biologics | Voluntary Action Indicated (VAI) | 3003098680 |
| Apr 25, 2024 | King Of Prussia, PA | Drugs | No Action Indicated (NAI) | 3000215763 |
| Mar 2, 2023 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Mar 4, 2022 | Marburg, Germany | Biologics | Voluntary Action Indicated (VAI) | 3003098680 |
| Sep 24, 2021 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Feb 18, 2020 | Bern, Switzerland | Biologics | Voluntary Action Indicated (VAI) | 3002806716 |
| May 23, 2019 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Oct 18, 2018 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Apr 13, 2018 | Bern, Switzerland | Biologics | Voluntary Action Indicated (VAI) | 3002806716 |
| Nov 9, 2017 | King Of Prussia, PA | Drugs | No Action Indicated (NAI) | 3000215763 |
| Jul 19, 2017 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Sep 29, 2016 | Bern, Switzerland | Biologics | Voluntary Action Indicated (VAI) | 3002806716 |
| May 17, 2016 | Marburg, Germany | Biologics | Voluntary Action Indicated (VAI) | 3003098680 |
| Sep 1, 2015 | Bradley, IL | Devices | No Action Indicated (NAI) | 1410248 |
| Jul 17, 2015 | Bradley, IL | Biologics | Voluntary Action Indicated (VAI) | 1410248 |
| Jul 28, 2014 | Bradley, IL | Drugs | Voluntary Action Indicated (VAI) | 1410248 |
| Jun 19, 2014 | Bern, Switzerland | Biologics | Voluntary Action Indicated (VAI) | 3002806716 |
| May 30, 2013 | Bradley, IL | Drugs | No Action Indicated (NAI) | 1410248 |
| Sep 14, 2012 | King Of Prussia, PA | Biologics | Voluntary Action Indicated (VAI) | 3000215763 |
| Sep 10, 2012 | Bradley, IL | Biologics | No Action Indicated (NAI) | 1410248 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under CSL Behring GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003098680 | Marburg, Germany | 5 | Feb 18, 2026 |
| FEI 3000215763 | King Of Prussia, PA | 3 | Apr 25, 2024 |
| FEI 1410248 | Bradley, IL | 13 | Mar 2, 2023 |
| FEI 3002806716 | Bern, Switzerland | 6 | Feb 18, 2020 |
CSL Behring GmbH and the FDA: common questions
Has CSL Behring GmbH received an FDA warning letter?
Yes. FDA has issued 1 warning letter to CSL Behring GmbH. The most recent is dated Sep 9, 2025, with the subject "Advertising & Promotional Labeling/Drugs/Biological Products".
Has CSL Behring GmbH received an FDA Form 483?
FDA has published 3 Form 483s for CSL Behring GmbH in its reading room, the most recent dated Feb 18, 2026. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CSL Behring GmbH?
The most recent FDA inspection on file ended Feb 18, 2026 at Marburg, Germany and was classified VAI. FDA has 27 inspections of CSL Behring GmbH on file.
Has CSL Behring GmbH had an FDA recall?
Yes. CSL Behring GmbH has 5 FDA recalls on record. The most recent started Mar 2, 2020.
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