Biotronik SE & Co. KG FDA Record
Biotronik SE & Co. KG has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Biotronik SE & Co. KG, the most recent on Sep 1, 2016.
- Latest inspection
- Jun 22, 2017 · NAI
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 | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Biotronik SE & Co. KG FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 1, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 22, 2017 | Berlin, Germany | Devices | No Action Indicated (NAI) | 3002806500 |
| Mar 10, 2016 | Berlin, Germany | Devices | Official Action Indicated (OAI) | 3002806500 |
| Aug 13, 2013 | Berlin, Germany | Devices | Voluntary Action Indicated (VAI) | 3002806500 |
| Aug 18, 2011 | Berlin, Germany | Devices | Voluntary Action Indicated (VAI) | 3002806500 |
| Jul 2, 2009 | Berlin, Germany | Devices | No Action Indicated (NAI) | 3002806500 |
- 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 Biotronik SE & Co. KG: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002806500 | Berlin, Germany | 5 | Jun 22, 2017 |
Biotronik SE & Co. KG and the FDA: common questions
Has Biotronik SE & Co. KG received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Biotronik SE & Co. KG. The most recent is dated Sep 1, 2016.
Has Biotronik SE & Co. KG received an FDA Form 483?
FDA has not published a Form 483 for "Biotronik SE & Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Biotronik SE & Co. KG?
The most recent FDA inspection on file ended Jun 22, 2017 at Berlin, Germany and was classified NAI. FDA has 5 inspections of Biotronik SE & Co. KG on file, 1 of them classified OAI (official action indicated).
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