FEI 1421101Initial importer
Instrumed International Inc Dba Avalign German Specialty Instruments
626 Cooper Ct, SCHAUMBURG, IL, US
MDR events2All time
Recalls0All time
Registered products241
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
241 product codes
Recent MDR events
2 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1421101.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 5, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 5, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.40(a)Dec 5, 2023
Document locations, Dissemination, etc.
- 21 CFR 820.50Dec 5, 2023
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Dec 5, 2023
Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.100(a)Dec 5, 2023
Lack of or inadequate procedures
- 21 CFR 820.100(b)Dec 5, 2023
Documentation
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.