Shikani Medical Llc
1629 York Road, Lutherville, MD, US
Registered product codes
3 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3008278458.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 21, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 21, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.20(b)Lack of or inadequate organizational structure
121 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(j)Design history file
121 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.20(b)Dec 21, 2023
Lack of or inadequate organizational structure
- 21 CFR 820.25(b)Dec 21, 2023
Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Dec 21, 2023
Design history file
- 21 CFR 820.50(a)(1)Dec 21, 2023
Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Dec 21, 2023
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Dec 21, 2023
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.