Hebei Pukang Medical Instruments Co., Ltd. FDA Record
- Latest inspection OAI · Jan 12, 2017
- Last warning letter 2017
Hebei Pukang Medical Instruments Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Hebei Pukang Medical Instruments Co., Ltd., the most recent on Mar 29, 2017.
- Latest inspection
- Jan 12, 2017 · OAI
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 | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Hebei Pukang Medical Instruments Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 29, 2017 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 12, 2017 | Baoding, China | Devices | Official Action Indicated (OAI) | 3007744192 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Hebei Pukang Medical Instruments Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007744192 | Baoding, China | 1 | Jan 12, 2017 |
Hebei Pukang Medical Instruments Co., Ltd. and the FDA: common questions
Has Hebei Pukang Medical Instruments Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Hebei Pukang Medical Instruments Co., Ltd.. The most recent is dated Mar 29, 2017.
Has Hebei Pukang Medical Instruments Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Hebei Pukang Medical Instruments Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hebei Pukang Medical Instruments Co., Ltd.?
The most recent FDA inspection on file ended Jan 12, 2017 at Baoding, China and was classified OAI. FDA has 1 inspection of Hebei Pukang Medical Instruments Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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