Beijing HKKY Medical Tech. Co., Ltd. FDA Record
Beijing HKKY Medical Tech. Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Beijing HKKY Medical Tech. Co., Ltd." is on file.
- Latest inspection
- Jul 12, 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 |
|---|---|---|---|---|
| Jul 12, 2019 | Beijing, China | Drugs | Voluntary Action Indicated (VAI) | 3013159466 |
- 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 3013159466 | Beijing, China | 1 | Jul 12, 2019 |
Beijing HKKY Medical Tech. Co., Ltd. and the FDA: common questions
Has Beijing HKKY Medical Tech. Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Beijing HKKY Medical Tech. 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 Beijing HKKY Medical Tech. Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Beijing HKKY Medical Tech. Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Beijing HKKY Medical Tech. Co., Ltd.?
The most recent FDA inspection on file ended Jul 12, 2019 at Beijing, China and was classified VAI. FDA has 1 inspection of Beijing HKKY Medical Tech. Co., Ltd. on file.
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