CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY FDA Record
- Latest inspection NAI · Jun 11, 2015
- No warning letters matched by name
CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY" is on file.
- Latest inspection
- Jun 11, 2015 · 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 | 2 | 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 11, 2015 | Suzhou, China | Devices | No Action Indicated (NAI) | 3014607444 |
| Jun 27, 2013 | Suzhou, China | Devices | No Action Indicated (NAI) | 3014607444 |
- 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 3014607444 | Suzhou, China | 2 | Jun 11, 2015 |
CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY and the FDA: common questions
Has CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY received an FDA warning letter?
No FDA warning letter addressed to the name "CHANGSHU KANGBAO MEDICAL APPLIANCE 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 CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY received an FDA Form 483?
FDA has not published a Form 483 for "CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY?
The most recent FDA inspection on file ended Jun 11, 2015 at Suzhou, China and was classified NAI. FDA has 2 inspections of CHANGSHU KANGBAO MEDICAL APPLIANCE FACTORY on file.
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