Nibec Co., Ltd. FDA Record
Nibec Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nibec Co., Ltd." is on file.
- Latest inspection
- Jul 21, 2017 · VAI
- Latest 510(k)
- Dec 10, 2015
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 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 |
|---|---|---|---|---|
| Jul 21, 2017 | Jincheon, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3007679154 |
- 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 3007679154 | Jincheon, Korea (The Republic Of) | 1 | Jul 21, 2017 |
Nibec Co., Ltd. and the FDA: common questions
Has Nibec Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Nibec 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 Nibec Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Nibec Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nibec Co., Ltd.?
The most recent FDA inspection on file ended Jul 21, 2017 at Jincheon, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Nibec Co., Ltd. on file.
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