Diora Kimya Sanayi Ve Ticaret Limited Sirketi FDA Record
- Latest inspection OAI · May 31, 2024
- Last warning letter 2024
Diora Kimya Sanayi Ve Ticaret Limited Sirketi has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Diora Kimya Sanayi Ve Ticaret Limited Sirketi, the most recent on Oct 17, 2024.
- Latest inspection
- May 31, 2024 · OAI
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 | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Diora Kimya Sanayi Ve Ticaret Limited Sirketi FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Oct 17, 2024 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register | Center for Drug Evaluation and Research (CDER) |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 31, 2024 | Gaziantep, Turkey | Drugs | Official Action Indicated (OAI) | 3013927966 |
- 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 Diora Kimya Sanayi Ve Ticaret Limited Sirketi: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3013927966 | Gaziantep, Turkey | 1 | May 31, 2024 |
Diora Kimya Sanayi Ve Ticaret Limited Sirketi and the FDA: common questions
Has Diora Kimya Sanayi Ve Ticaret Limited Sirketi received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Diora Kimya Sanayi Ve Ticaret Limited Sirketi. The most recent is dated Oct 17, 2024, with the subject "CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register".
Has Diora Kimya Sanayi Ve Ticaret Limited Sirketi received an FDA Form 483?
FDA has not published a Form 483 for "Diora Kimya Sanayi Ve Ticaret Limited Sirketi" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Diora Kimya Sanayi Ve Ticaret Limited Sirketi?
The most recent FDA inspection on file ended May 31, 2024 at Gaziantep, Turkey and was classified OAI. FDA has 1 inspection of Diora Kimya Sanayi Ve Ticaret Limited Sirketi on file, 1 of them classified OAI (official action indicated).
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