FEI 3003477135
Quality Tech Services, Llc
10525 Hampshire Ave. S., Bloomington, MN, US
MDR events177All time
Recalls0All time
Registered products149
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
149 product codes
Recent MDR events
177 on file
- SENSIGHTJul 4, 2025Malfunction3012165443-2025-00039
- SENSIGHTJun 23, 2025Malfunction3012165443-2025-00037
- SENSIGHTJun 16, 2025Malfunction3012165443-2025-00036
- SENSIGHTJun 9, 2025Malfunction3012165443-2025-00035
- SENSIGHTMay 20, 2025Malfunction2182207-2025-01360
- STIMLOCMay 19, 2025Malfunction3012165443-2025-00032
- SENSIGHTMay 9, 2025Malfunction3012165443-2025-00031
- SENSIGHTApr 30, 2025Malfunction3012165443-2025-00030
- SENSIGHTApr 25, 2025Injury3012165443-2025-00029
- PASSIVE BIOPSY NEEDLEApr 23, 2025Malfunction1723170-2025-01758
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3003477135.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Jun 17, 2025
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(e)Jun 17, 2025
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jun 17, 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.