FEI 1000515493
Remel Cleveland, A Division Of Remel Inc.
1 Thermo Fisher Way, Oakwood Village, OH, US
MDR events5All time
Recalls0All time
Registered products10
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
10 product codes
Recent MDR events
5 on file
- THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MICJul 20, 2022MalfunctionMW5111028
- THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MICJul 20, 2022MW5111030
- THERMO FISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC OR BREAKPOINT SUSCEPTIBILITYJul 19, 2022MalfunctionMW5110998
- THERMO FISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC OR BREAKPOINT SUSCEPTIBILITYJul 6, 2022MalfunctionMW5110708
- THERMO FISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC OR BREAKPOINT SUSCEPTIBILITYJun 10, 2022MalfunctionMW5110263
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000515493.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 3, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 3, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Feb 3, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(a)Feb 3, 2025
Lack of or inadequate 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.