CMIC CMO Co., Ltd. Nishine Plant FDA Record
- Latest inspection NAI · Aug 7, 2026
- No warning letters matched by name
CMIC CMO Co., Ltd. Nishine Plant has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CMIC CMO Co., Ltd. Nishine Plant" is on file.
- Latest inspection
- Aug 7, 2026 · NAI
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 |
|---|---|---|---|---|
| Aug 7, 2026 | Hachimantai, Japan | Drugs | No Action Indicated (NAI) | 3030612875 |
- 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 3030612875 | Hachimantai, Japan | 1 | Aug 7, 2026 |
CMIC CMO Co., Ltd. Nishine Plant and the FDA: common questions
Has CMIC CMO Co., Ltd. Nishine Plant received an FDA warning letter?
No FDA warning letter addressed to the name "CMIC CMO Co., Ltd. Nishine Plant" 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 Co., Ltd. Nishine Plant received an FDA Form 483?
FDA has not published a Form 483 for "CMIC CMO Co., Ltd. Nishine Plant" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CMIC CMO Co., Ltd. Nishine Plant?
The most recent FDA inspection on file ended Aug 7, 2026 at Hachimantai, Japan and was classified NAI. FDA has 1 inspection of CMIC CMO Co., Ltd. Nishine Plant on file.
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