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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Neurotris, Inc. dba A1 Engineering

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 adequately establish and maintain procedures for design validation as required by 21 CFR 820.30(g).

Passage 2

Failure to adequately establish and maintain procedures for corrective and preventive action as required by 21 CFR 820.100.

Passage 3

Failure to adequately establish and maintain procedures for rework as required by 21 CFR 820.90(b)(2).

Passage 4

Failure to evaluate and select potential suppliers on their ability to meet specified requirements and define the type and extent of control to be exercised over suppliers as required by 21 CFR 820.50(a).

Citations in the original letter

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

  • 21 CFR 807.81(b)(1)
  • 21 CFR 807.81(a)
  • 21 CFR 820.30(g)
  • 21 CFR 820.100
  • 21 CFR 820.90(b)(2)
  • 21 CFR 820.50(a)
  • 21 CFR 882.5890
  • 21 CFR 882.1320
  • 21 CFR 882.1275
  • 21 CFR 890.5850
  • 21 CFR 890.5525