FDA Inspection
Sekisui Medical Co., LtdSekisui Medical Co., Ltd – FDA Inspection, Jun 11, 2026
Record Details
This FDA Inspection record concerns Sekisui Medical Co., Ltd, with an inspection on June 11, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · cf45c43f-f406-4676-849f-89c1c9a6c211
Inspection Facts
- Inspection number
- 1324302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
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Other FDA inspections of Sekisui Medical Co., Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sekisui Medical Co., Ltd
- FDA Inspection 1238155 - 2024-04-18
- FDA Inspection 1109094 - 2019-10-17
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