FDA Inspection
Shikani Medical, LLC dba The Airway CompanyShikani Medical, LLC dba The Airway Company – FDA Inspection, Aug 22, 2011
Record Details
This FDA Inspection record concerns Shikani Medical, LLC dba The Airway Company, with an inspection on August 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 22, 2011
- Product Type
- Devices
View Company Profile
ID · e8eeed84-cefa-4416-892d-3dc3459d9006
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740484
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR 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 |
|---|---|---|---|
| December 21, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shikani Medical, LLC dba The Airway Company
- FDA Inspection 1225666 - 2023-12-21
- FDA Inspection 945497 - 2015-10-09
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