FDA Inspection
BK Meditech Co., Ltd.BK Meditech Co., Ltd. – FDA Inspection, Mar 9, 2017
Record Details
This FDA Inspection record concerns BK Meditech Co., Ltd., with an inspection on March 9, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f3cfc861-97fd-4f3f-b48f-58a382583fb1
Inspection Facts
- Inspection number
- 1018160
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of BK Meditech Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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