Siegfried Hameln GmbH FDA Record
Siegfried Hameln GmbH has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Siegfried Hameln GmbH, the most recent on Dec 21, 2012.
- Latest inspection
- Aug 29, 2024 · 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 | 7 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 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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Siegfried Hameln GmbH FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Dec 21, 2012 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 29, 2024 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
| Sep 1, 2022 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
| Apr 24, 2018 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
| Jul 1, 2016 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
| Jul 25, 2014 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
| Jun 14, 2012 | Hameln, Germany | Drugs | Official Action Indicated (OAI) | 3002807877 |
| Nov 9, 2009 | Hameln, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807877 |
- 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 Siegfried Hameln GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807877 | Hameln, Germany | 7 | Aug 29, 2024 |
Siegfried Hameln GmbH and the FDA: common questions
Has Siegfried Hameln GmbH received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Siegfried Hameln GmbH. The most recent is dated Dec 21, 2012.
Has Siegfried Hameln GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Siegfried Hameln GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Siegfried Hameln GmbH?
The most recent FDA inspection on file ended Aug 29, 2024 at Hameln, Germany and was classified VAI. FDA has 7 inspections of Siegfried Hameln GmbH on file, 1 of them classified OAI (official action indicated).
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