FDA Inspection
Medexel Co., Ltd.Medexel Co., Ltd. – FDA Inspection, Feb 27, 2025
Record Details
This FDA Inspection record concerns Medexel Co., Ltd., with an inspection on February 27, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ec8d52f9-98cc-4f36-9d26-be6c9c52add1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Medexel Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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