Takeda GmbH, Plant Oranienburg FDA Record
- Latest inspection VAI · Nov 28, 2025
- No warning letters matched by name
Takeda GmbH, Plant Oranienburg has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Takeda GmbH, Plant Oranienburg" is on file.
- Latest inspection
- Nov 28, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 7 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Takeda GmbH, Plant Oranienburg: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 28, 2025 | Oranienburg, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807809 |
| Oct 30, 2020 | Oranienburg, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807809 |
| Mar 16, 2018 | Oranienburg, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807809 |
| Mar 11, 2016 | Oranienburg, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807809 |
| Nov 15, 2013 | Oranienburg, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807809 |
| Sep 16, 2011 | Oranienburg, Germany | Drugs | No Action Indicated (NAI) | 3002807809 |
| Nov 6, 2008 | Oranienburg, Germany | Drugs | No Action Indicated (NAI) | 3002807809 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807809 | Oranienburg, Germany | 7 | Nov 28, 2025 |
Takeda GmbH, Plant Oranienburg and the FDA: common questions
Has Takeda GmbH, Plant Oranienburg received an FDA warning letter?
No FDA warning letter addressed to the name "Takeda GmbH, Plant Oranienburg" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Takeda GmbH, Plant Oranienburg received an FDA Form 483?
FDA has not published a Form 483 for "Takeda GmbH, Plant Oranienburg" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Takeda GmbH, Plant Oranienburg?
The most recent FDA inspection on file ended Nov 28, 2025 at Oranienburg, Germany and was classified VAI. FDA has 7 inspections of Takeda GmbH, Plant Oranienburg on file.
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