Company
United StatesShikani Medical, LLC dba The Airway Company, Lutherville, MD – FDA Inspections
Inspection records and compliance data for Shikani Medical, LLC dba The Airway Company in Lutherville, Maryland. 3 FDA inspections on record, 1 Form 483, last inspected December 21, 2023.
Company Profile
This profile covers Shikani Medical, LLC dba The Airway Company based in Lutherville, Maryland, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 22, 2011. Last inspected December 21, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Acceptable supplier records, inadequate records1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 21, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1225666 |
| October 9, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 945497 |
| August 22, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 740484 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Shikani Medical, LLC dba The Airway Company
FEI Number
3008278458
Address
1629 York Rd Ste B, Lutherville, Maryland 21093, United States
Country
United States
ID: e17b9bf1-6f31-461f-be31-621774256f11