All Quality & Services, Inc.
47817 Fremont Blvd, Fremont, CA, US
Registered product codes
13 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 1000548922.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 10, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 10, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
1ISO 13485:2016 Clause 5.6.1Management review records not maintained
1ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
1ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
1ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
1
- 21 CFR 803.17Apr 10, 2026
Lack of Written MDR Procedures
- ISO 13485:2016 Clause 5.6.1Apr 10, 2026
Management review records not maintained
- ISO 13485:2016 Clause 6.2Apr 10, 2026
Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 8.3.1Apr 10, 2026
Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Apr 10, 2026
Corrective action procedures not documented
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.