Shenzhen Shinhop Laser Equipment Co. Ltd. FDA Record
- Latest inspection VAI · May 21, 2019
- No warning letters matched by name
Shenzhen Shinhop Laser Equipment Co. Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Shenzhen Shinhop Laser Equipment Co. Ltd." is on file.
- Latest inspection
- May 21, 2019 · 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 | 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 |
|---|---|---|---|---|
| May 21, 2019 | Shenzhen, China | Devices | Voluntary Action Indicated (VAI) | 3014842360 |
- 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 3014842360 | Shenzhen, China | 1 | May 21, 2019 |
Shenzhen Shinhop Laser Equipment Co. Ltd. and the FDA: common questions
Has Shenzhen Shinhop Laser Equipment Co. Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Shenzhen Shinhop Laser Equipment 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 Shenzhen Shinhop Laser Equipment Co. Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Shenzhen Shinhop Laser Equipment Co. Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shenzhen Shinhop Laser Equipment Co. Ltd.?
The most recent FDA inspection on file ended May 21, 2019 at Shenzhen, China and was classified VAI. FDA has 1 inspection of Shenzhen Shinhop Laser Equipment Co. Ltd. on file.
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