System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh FDA Record
- Latest inspection OAI · Feb 18, 2022
- Last warning letter 2022
System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh, the most recent on Sep 9, 2022.
- Latest inspection
- Feb 18, 2022 · OAI
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 | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 9, 2022 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research | CDER |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 18, 2022 | Munster, Germany | Drugs | Official Action Indicated (OAI) | 3011408975 |
- 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 System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3011408975 | Munster, Germany | 1 | Feb 18, 2022 |
System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh and the FDA: common questions
Has System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh received an FDA warning letter?
Yes. FDA has issued 1 warning letter to System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh. The most recent is dated Sep 9, 2022, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".
Has System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh received an FDA Form 483?
FDA has not published a Form 483 for "System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh?
The most recent FDA inspection on file ended Feb 18, 2022 at Munster, Germany and was classified OAI. FDA has 1 inspection of System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh on file, 1 of them classified OAI (official action indicated).
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