Fantastic Bioimaging Co., Ltd. FDA Record
Fantastic Bioimaging Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fantastic Bioimaging Co., Ltd." is on file.
- Latest inspection
- Apr 17, 2025 · NAI
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 | 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 |
|---|---|---|---|---|
| Apr 17, 2025 | Shanghai, China | Drugs | No Action Indicated (NAI) | 3033712377 |
- 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 3033712377 | Shanghai, China | 1 | Apr 17, 2025 |
Fantastic Bioimaging Co., Ltd. and the FDA: common questions
Has Fantastic Bioimaging Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Fantastic Bioimaging 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 Fantastic Bioimaging Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Fantastic Bioimaging Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Fantastic Bioimaging Co., Ltd.?
The most recent FDA inspection on file ended Apr 17, 2025 at Shanghai, China and was classified NAI. FDA has 1 inspection of Fantastic Bioimaging Co., Ltd. on file.
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