Curasan Ag, Frankfurt Facility FDA Record
Curasan Ag, Frankfurt Facility has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Curasan Ag, Frankfurt Facility, the most recent on Aug 23, 2017.
- Latest inspection
- May 11, 2017 · OAI
- Latest 510(k)
- Jul 22, 2005
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Curasan Ag, Frankfurt Facility FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 23, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 11, 2017 | Frankfurt Am Main, Germany | Devices | Official Action Indicated (OAI) | 3004847139 |
- 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 Curasan Ag, Frankfurt Facility: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004847139 | Frankfurt Am Main, Germany | 1 | May 11, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K051443 | CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO | Jul 22, 2005 |
Curasan Ag, Frankfurt Facility and the FDA: common questions
Has Curasan Ag, Frankfurt Facility received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Curasan Ag, Frankfurt Facility. The most recent is dated Aug 23, 2017.
Has Curasan Ag, Frankfurt Facility received an FDA Form 483?
FDA has not published a Form 483 for "Curasan Ag, Frankfurt Facility" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Curasan Ag, Frankfurt Facility?
The most recent FDA inspection on file ended May 11, 2017 at Frankfurt Am Main, Germany and was classified OAI. FDA has 1 inspection of Curasan Ag, Frankfurt Facility on file, 1 of them classified OAI (official action indicated).
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