PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. FDA Record
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD." is on file.
- Latest inspection
- Jun 26, 2025 · 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 | 3 | 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 |
|---|---|---|---|---|
| Jun 26, 2025 | Changzhou, China | Devices | Voluntary Action Indicated (VAI) | 3007539489 |
| Oct 27, 2016 | Changzhou, China | Devices | No Action Indicated (NAI) | 3007539489 |
| May 16, 2013 | Changzhou, China | Devices | No Action Indicated (NAI) | 3007539489 |
- 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 3007539489 | Changzhou, China | 3 | Jun 26, 2025 |
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. and the FDA: common questions
Has PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. received an FDA warning letter?
No FDA warning letter addressed to the name "PARAGON MEDICAL DEVICE (CHANGZHOU) 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 PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. received an FDA Form 483?
FDA has not published a Form 483 for "PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.?
The most recent FDA inspection on file ended Jun 26, 2025 at Changzhou, China and was classified VAI. FDA has 3 inspections of PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. on file.
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