FDA Inspection
Koning CorporationKoning Corporation – FDA Inspection, Feb 10, 2016
Record Details
This FDA Inspection record concerns Koning Corporation, with an inspection on February 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Koning Corporation
- Inspection Date
- February 10, 2016
- Product Type
- Devices
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ID · fefeef1b-d00e-4b98-94c2-d78e84e7ad67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 961418
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Koning Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2025 | NAI | Atlanta District Office | Postmarket Assurance: Medical Devices |
| July 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 19, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Koning Corporation
- FDA Inspection 1276569 - 2025-07-21
- FDA Inspection 886820 - 2014-07-08
- FDA Inspection 882197 - 2014-05-19
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