Kolmar Korea Co., Ltd. Bucheon Factory FDA Record
- Latest inspection VAI · Dec 6, 2024
- No warning letters matched by name
Kolmar Korea Co., Ltd. Bucheon Factory has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kolmar Korea Co., Ltd. Bucheon Factory" is on file.
- Latest inspection
- Dec 6, 2024 · VAI
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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Kolmar Korea Co., Ltd. Bucheon Factory: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Reviewing Kolmar Korea Co., Ltd. Bucheon Factory as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Kolmar Korea Co., Ltd. Bucheon Factory yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 6, 2024 | Bucheon, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3010818961 |
| Mar 22, 2019 | Bucheon, Korea (The Republic Of) | Drugs | No Action Indicated (NAI) | 3010818961 |
- 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 3010818961 | Bucheon, Korea (The Republic Of) | 2 | Dec 6, 2024 |
Kolmar Korea Co., Ltd. Bucheon Factory and the FDA: common questions
Has Kolmar Korea Co., Ltd. Bucheon Factory received an FDA warning letter?
No FDA warning letter addressed to the name "Kolmar Korea Co., Ltd. Bucheon Factory" 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 Kolmar Korea Co., Ltd. Bucheon Factory received an FDA Form 483?
FDA has not published a Form 483 for "Kolmar Korea Co., Ltd. Bucheon Factory" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kolmar Korea Co., Ltd. Bucheon Factory?
The most recent FDA inspection on file ended Dec 6, 2024 at Bucheon, Korea (The Republic Of) and was classified VAI. FDA has 2 inspections of Kolmar Korea Co., Ltd. Bucheon Factory on file.
Need more than this page shows? Ask about Kolmar Korea Co., Ltd. Bucheon Factory in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.