FDA Inspection
Medicore Co., Ltd.Medicore Co., Ltd. – FDA Inspection, May 20, 2026
Record Details
This FDA Inspection record concerns Medicore Co., Ltd., with an inspection on May 20, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d0fcee08-1df9-4802-9022-bfec4e1a06c9
Inspection Facts
- Inspection number
- 1320334
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Medicore Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | Not classified | Office of Inspections and Investigations | |
| April 25, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medicore Co., Ltd.
- FDA Inspection 1224126 - 2023-11-09
- FDA Inspection 1091675 - 2019-04-25
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