FDA Inspection
Kub Technologies, Inc.Kub Technologies, Inc. – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns Kub Technologies, Inc., with an inspection on December 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kub Technologies, Inc.
- Inspection Date
- December 18, 2009
- Product Type
- Devices
View Company Profile
ID · 8b5d1fe7-0486-4026-9407-4914b7dada48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635740
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - validation vs. verification
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.184(d)Acceptance records
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Other FDA inspections of Kub Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 17, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Kub Technologies, Inc.
- FDA Inspection 1234862 - 2024-12-19
- FDA Inspection 1097256 - 2019-07-16
- FDA Inspection 1002194 - 2017-02-23
- FDA Inspection 833233 - 2013-05-17
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