FDA Inspection
JKH Health Co., LtdJKH Health Co., Ltd – FDA Inspection, Oct 31, 2024
Record Details
This FDA Inspection record concerns JKH Health Co., Ltd, with an inspection on October 31, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 5e66f03d-e138-4f8f-a1d3-2c0e1be556f4
Inspection Facts
- Inspection number
- 1253982
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of JKH Health Co., Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2023 | Not classified | Office of Inspections and Investigations | |
| February 8, 2018 | Not classified | Office of Inspections and Investigations | |
| November 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for JKH Health Co., Ltd
- FDA Inspection 1215642 - 2023-07-27
- FDA Inspection 1042808 - 2018-02-08
- FDA Inspection 905697 - 2014-11-06
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