KLS Martin SE & Co. KG FDA Record
KLS Martin SE & Co. KG has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "KLS Martin SE & Co. KG" is on file.
- Latest inspection
- Apr 9, 2025 · 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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 9, 2025 | Muhlheim An Der Donau, Germany | Devices | No Action Indicated (NAI) | 3002807464 |
| Sep 28, 2011 | Muhlheim An Der Donau, Germany | Devices | Voluntary Action Indicated (VAI) | 3002807464 |
- 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 3002807464 | Muhlheim An Der Donau, Germany | 2 | Apr 9, 2025 |
KLS Martin SE & Co. KG and the FDA: common questions
Has KLS Martin SE & Co. KG received an FDA warning letter?
No FDA warning letter addressed to the name "KLS Martin SE & Co. KG" 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 KLS Martin SE & Co. KG received an FDA Form 483?
FDA has not published a Form 483 for "KLS Martin SE & Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect KLS Martin SE & Co. KG?
The most recent FDA inspection on file ended Apr 9, 2025 at Muhlheim An Der Donau, Germany and was classified NAI. FDA has 2 inspections of KLS Martin SE & Co. KG on file.
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