BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Medical Devices

NeuroSync, Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically:

Passage 2

Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. You have not implemented your Supplier Management Procedure, SOP-10025, Rev 004. Specifically:

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 801.20(a)
  • 21 CFR 801.3
  • 21 CFR 801.40(a)(1)
  • 21 CFR 801.40(a)(2)
  • 21 CFR 801
  • 21 CFR 806.10
  • 21 CFR 806
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(f)
  • 21 CFR 820.30(i)
  • 21 CFR 820.30(c)
  • 21 CFR 820.30(g)
  • 21 CFR 820.100(a)(5)
  • 21 CFR 820.50
  • 21 CFR 820.80(a)
  • 21 CFR 830