FDA Inspection
Kawasumi Laboratories (Thailand) Co., Ltd.Kawasumi Laboratories (Thailand) Co., Ltd. – FDA Inspection, May 9, 2024
Record Details
This FDA Inspection record concerns Kawasumi Laboratories (Thailand) Co., Ltd., with an inspection on May 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · baa09eb9-646a-4fbc-8cf3-330d5b194e99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240297
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Kawasumi Laboratories (Thailand) Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kawasumi Laboratories (Thailand) Co., Ltd.
- FDA Inspection 611191 - 2009-08-06
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