FDA Inspection
BM Korea Co. Ltd.BM Korea Co. Ltd. – FDA Inspection, Jan 18, 2023
Record Details
This FDA Inspection record concerns BM Korea Co. Ltd., with an inspection on January 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd69a524-618f-4b03-9a41-e0844e78902e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195668
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of BM Korea Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BM Korea Co. Ltd.
- FDA Inspection 952122 - 2015-11-05
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