CMIC CMO Korea Co., Ltd. FDA Record
- Latest inspection VAI · Jun 15, 2018
- No warning letters matched by name
CMIC CMO Korea Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CMIC CMO Korea Co., Ltd." is on file.
- Latest inspection
- Jun 15, 2018 · VAI
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 |
|---|---|---|---|---|
| Jun 15, 2018 | Bucheon, Korea (The Republic Of) | Drugs | Voluntary Action Indicated (VAI) | 3013212450 |
- 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 3013212450 | Bucheon, Korea (The Republic Of) | 1 | Jun 15, 2018 |
CMIC CMO Korea Co., Ltd. and the FDA: common questions
Has CMIC CMO Korea Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "CMIC CMO Korea 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 CMIC CMO Korea Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "CMIC CMO Korea Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CMIC CMO Korea Co., Ltd.?
The most recent FDA inspection on file ended Jun 15, 2018 at Bucheon, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of CMIC CMO Korea Co., Ltd. on file.
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