FDA Inspection
BONTECH CO., LTDBONTECH CO., LTD – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns BONTECH CO., LTD, with an inspection on September 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4314b7b7-12cb-42ba-ad5d-c62c052e393d
Inspection Facts
- Inspection number
- 1280384
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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