FDA Inspection
Jiangsu Suyun Medical Materials Co., Ltd.Jiangsu Suyun Medical Materials Co., Ltd. – FDA Inspection, Apr 10, 2026
Record Details
This FDA Inspection record concerns Jiangsu Suyun Medical Materials Co., Ltd., with an inspection on April 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 10, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 63707db1-fe07-4f4c-824e-b65faa1ccee8
Inspection Facts
- Inspection number
- 1314104
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.6(b)Adjustment to measuring equipment was not performed or recorded
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
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Other FDA inspections of Jiangsu Suyun Medical Materials Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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