FDA Inspection
Shikani Medical, LLC dba The Airway CompanyShikani Medical, LLC dba The Airway Company – FDA Inspection, Dec 21, 2023
Record Details
This FDA Inspection record concerns Shikani Medical, LLC dba The Airway Company, with an inspection on December 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 21, 2023
- Product Type
- Devices
View Company Profile
ID · 739e73d6-33e2-4917-b497-a470f0b37765
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225666
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shikani Medical, LLC dba The Airway Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shikani Medical, LLC dba The Airway Company
- FDA Inspection 945497 - 2015-10-09
- FDA Inspection 740484 - 2011-08-22
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