ITM Medical Isotopes GmbH FDA Record
- Latest inspection VAI · Feb 10, 2026
- No warning letters matched by name
ITM Medical Isotopes GmbH has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ITM Medical Isotopes GmbH" is on file.
- Latest inspection
- Feb 10, 2026 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
ITM Medical Isotopes GmbH: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 10, 2026 | Garching B. Munchen, Germany | Drugs | Voluntary Action Indicated (VAI) | 3010531211 |
| Mar 20, 2024 | Garching B. Munchen, Germany | Drugs | Voluntary Action Indicated (VAI) | 3010531211 |
| Nov 11, 2020 | Garching B. Munchen, Germany | Drugs | Voluntary Action Indicated (VAI) | 3010531211 |
- 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 3010531211 | Garching B. Munchen, Germany | 3 | Feb 10, 2026 |
ITM Medical Isotopes GmbH and the FDA: common questions
Has ITM Medical Isotopes GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "ITM Medical Isotopes GmbH" 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 ITM Medical Isotopes GmbH received an FDA Form 483?
FDA has not published a Form 483 for "ITM Medical Isotopes GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect ITM Medical Isotopes GmbH?
The most recent FDA inspection on file ended Feb 10, 2026 at Garching B. Munchen, Germany and was classified VAI. FDA has 3 inspections of ITM Medical Isotopes GmbH on file.
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