FDA Inspection
JOOWON INNOVATION CO, LTDJOOWON INNOVATION CO, LTD – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns JOOWON INNOVATION CO, LTD, with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- JOOWON INNOVATION CO, LTD
- Inspection Date
- September 17, 2026
- Product Type
- Medical Devices & Rad Health
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ID · abe38fa5-4ec2-4a2d-9d9b-c9e4cd0e6bb5
Inspection Facts
- Inspection number
- 1336242
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 4.2.3Medical device file does not contain specific requirements
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of JOOWON INNOVATION CO, LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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