FDA Inspection
Cogmedix, Inc.Cogmedix, Inc. – FDA Inspection, Apr 11, 2024
Record Details
This FDA Inspection record concerns Cogmedix, Inc., with an inspection on April 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9faa9b57-e9a8-4176-ae9a-6b4334868b43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235696
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 1002.20(a)Failure to report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cogmedix, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2018 | Not classified | New England District Office | |
| May 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cogmedix, Inc.
- FDA Inspection 1038648 - 2018-01-19
- FDA Inspection 834006 - 2013-05-31
- FDA Inspection 722907 - 2011-04-21
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