FDA Inspection
Sewoon Medical Co., Ltd.Sewoon Medical Co., Ltd. – FDA Inspection, Feb 20, 2025
Record Details
This FDA Inspection record concerns Sewoon Medical Co., Ltd., with an inspection on February 20, 2025, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
- Company
- Sewoon Medical Co., Ltd.
- Inspection Date
- February 20, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · eb900b39-9add-4e0b-a7d5-cd36d8981450
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1261809
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Sewoon Medical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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