FDA Inspection
Nipro (Thailand) Corporation LimitedNipro (Thailand) Corporation Limited – FDA Inspection, Sep 28, 2023
Record Details
This FDA Inspection record concerns Nipro (Thailand) Corporation Limited, with an inspection on September 28, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- September 28, 2023
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ID · 37501f28-1d13-477f-a85f-239f3406ab56
Inspection Facts
- Inspection number
- 1221178
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Nipro (Thailand) Corporation Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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