Kyungwon Medical Co., Ltd. FDA Record
- Latest inspection OAI · Sep 20, 2012
- No warning letters matched by name
Kyungwon Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kyungwon Medical Co., Ltd." is on file.
- Latest inspection
- Sep 20, 2012 · 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 | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 20, 2012 | Osong-Eup, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3006455376 |
- 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 3006455376 | Osong-Eup, Korea (The Republic Of) | 1 | Sep 20, 2012 |
Kyungwon Medical Co., Ltd. and the FDA: common questions
Has Kyungwon Medical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Kyungwon Medical Co., Ltd." 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 Kyungwon Medical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Kyungwon Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kyungwon Medical Co., Ltd.?
The most recent FDA inspection on file ended Sep 20, 2012 at Osong-Eup, Korea (The Republic Of) and was classified OAI. FDA has 1 inspection of Kyungwon Medical Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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