Merckle GmbH FDA Record
- Latest inspection NAI · Apr 25, 2013
- No warning letters matched by name
Merckle GmbH has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Merckle GmbH" is on file.
- Latest recall
- D-0038-2027 · Sep 29, 2026 · filed under Teva Pharmaceuticals Usa
- Latest inspection
- Apr 25, 2013 · NAI
Newer recall under related name Teva Pharmaceuticals Usa: Sep 29, 2026, D-0038-2027.
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 | 1 | Nov 15, 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 25, 2013 | Ulm, Germany | Drugs | No Action Indicated (NAI) | 1000616804 |
- 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 1000616804 | Ulm, Germany | 1 | Apr 25, 2013 |
Merckle GmbH and the FDA: common questions
Has Merckle GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Merckle 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 Merckle GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Merckle GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Merckle GmbH?
The most recent FDA inspection on file ended Apr 25, 2013 at Ulm, Germany and was classified NAI. FDA has 1 inspection of Merckle GmbH on file.
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