Emerald Supply
1558 E 37th St, Brooklyn, NY, US
Registered product codes
3 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3011714211.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 16, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 16, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.20(e)Quality System Procedures
121 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
121 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
121 CFR 820.50(b)Approval, inadequate purchasing data
1ISO 13485:2016 Clause 4.2.1Quality management system documentation not adequate
1
- 21 CFR 803.17Apr 16, 2026
Lack of Written MDR Procedures
- 21 CFR 820.20(e)Apr 16, 2026
Quality System Procedures
- 21 CFR 820.35(a)Apr 16, 2026
Records for complaints involving failure to meet specifications not maintained
- 21 CFR 820.50(a)(1)Apr 16, 2026
Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.50(b)Apr 16, 2026
Approval, inadequate purchasing data
- ISO 13485:2016 Clause 4.2.1Apr 16, 2026
Quality management system documentation not adequate
- ISO 13485:2016 Clause 5.1Apr 16, 2026
Lack of evidence for top management's commitment to QMS
- ISO 13485:2016 Clause 7.1Apr 16, 2026
Records of risk management activities in product realization not maintained
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.