FDA Inspection
Kawasumi Laboratories (Thailand) Co. Ltd.Kawasumi Laboratories (Thailand) Co. Ltd. – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns Kawasumi Laboratories (Thailand) Co. Ltd., with an inspection on July 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e169de12-228b-454f-96e0-07037ea14142
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1244549
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of Kawasumi Laboratories (Thailand) Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| June 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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