FDA Inspection
Vassen Co. Ltd.Vassen Co. Ltd. – FDA Inspection, May 14, 2026
Record Details
This FDA Inspection record concerns Vassen Co. Ltd., with an inspection on May 14, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4e985068-b02e-4e49-a27c-2060669f11ea
Inspection Facts
- Inspection number
- 1320332
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vassen Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vassen Co. Ltd.
- FDA Inspection 1226905 - 2023-12-14
- FDA Inspection 948870 - 2015-10-29
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