FEI 3017200972
Cognita Labs Llc
700 N MAIN ST, Santa Ana, CA, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
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 3017200972.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 13, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 13, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(b)(1)Dec 13, 2023
Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.184Dec 13, 2023
Lack of or inadequate DHR 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.