FDA Inspection
George King Bio-Medical, Inc.George King Bio-Medical, Inc. – FDA Inspection, Sep 6, 2017
Record Details
This FDA Inspection record concerns George King Bio-Medical, Inc., with an inspection on September 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 73e801d4-8e85-4261-91b3-118eadfa7b35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024197
- 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 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of George King Bio-Medical, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 13, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for George King Bio-Medical, Inc.
- FDA Inspection 1276234 - 2025-07-16
- FDA Inspection 1181783 - 2022-10-13
- FDA Inspection 991776 - 2016-10-27
- FDA Inspection 903607 - 2014-11-13
- FDA Inspection 803190 - 2012-10-16
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