Neurosync, Inc.
118 Washington Street, Holliston, MA, US
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Compliance history
Matched by FEI 3014133165.
FDA inspections
2 on file
- Official Action Indicated (OAI)Feb 5, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Feb 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
12 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 806.20(b)(4)Justification for not reporting
121 CFR 820.30(c)Design input - Lack of or inadequate procedures
121 CFR 820.30(f)Design verification - output does not meet input requirement
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
1
- 21 CFR 801.20(a)Feb 5, 2025
Label to bear a unique device identifier
- 21 CFR 806.20(b)(4)Feb 5, 2025
Justification for not reporting
- 21 CFR 820.30(c)Feb 5, 2025
Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Feb 5, 2025
Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Feb 5, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Feb 5, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Feb 5, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Feb 5, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Feb 5, 2025
Lack of or inadequate procedures
- 21 CFR 820.184Feb 5, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Feb 5, 2025
Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Feb 5, 2025
Devices subject to device identification GUDID data submission requirements.
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.