Sino Protection (Hefei) Medical Products Co. Ltd. FDA Record
- Latest inspection NAI · Dec 13, 2018
- No warning letters matched by name
Sino Protection (Hefei) Medical Products Co. Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sino Protection (Hefei) Medical Products Co. Ltd." is on file.
- Latest inspection
- Dec 13, 2018 · 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 |
|---|---|---|---|---|
| Dec 13, 2018 | Hefei, China | Devices | No Action Indicated (NAI) | 3004362278 |
| May 15, 2014 | Hefei, China | Devices | Voluntary Action Indicated (VAI) | 3004362278 |
- 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 3004362278 | Hefei, China | 2 | Dec 13, 2018 |
Sino Protection (Hefei) Medical Products Co. Ltd. and the FDA: common questions
Has Sino Protection (Hefei) Medical Products Co. Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Sino Protection (Hefei) Medical Products 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 Sino Protection (Hefei) Medical Products Co. Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Sino Protection (Hefei) Medical Products Co. Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sino Protection (Hefei) Medical Products Co. Ltd.?
The most recent FDA inspection on file ended Dec 13, 2018 at Hefei, China and was classified NAI. FDA has 2 inspections of Sino Protection (Hefei) Medical Products Co. Ltd. on file.
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