FEI 3002786339Initial importer
Gsource, Llc.
19 Bland St, EMERSON, NJ, US
MDR events17All time
Recalls0All time
Registered products117
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
117 product codes
Recent MDR events
17 on file
- GSOURCEApr 28, 2026Malfunction2249529-2026-00001
- GSOURCEOct 29, 2025Malfunction2249529-2025-00005
- GSOURCEOct 8, 2025Malfunction2249529-2025-00004
- GSOURCE SHORT DRILL BITAug 26, 2025MalfunctionMW5175240
- DRILL BIT SQC 2.5MM 110/32MMMar 18, 2025Malfunction2249529-2025-00002
- GSOURCE, LLCJan 7, 2025Malfunction2249529-2025-00001
- TWIST DRILL 5" STR SHANK DOUBLEDec 11, 2024MalfunctionMW5163564
- DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MMSep 23, 2024Injury2249529-2024-00001
- DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MMSep 23, 2024Malfunction2249529-2024-00002
- DRILL BIT SQC 2.0MM 100/21.5MMAug 21, 2024MalfunctionMW5158653
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002786339.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 30, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 30, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17(a)(2)Jul 30, 2024
Lack of System for Determining MDR Events
- 21 CFR 820.198(a)Jul 30, 2024
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.