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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Technological Medical Advancements LLC

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 procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50.Specifically,

Passage 2

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to maintain complaint files, as required by 21CFR 820.198(a). For example:

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 807.81(b)
  • 21 CFR 820.50
  • 21 CFR 820.198(a)
  • 21 CFR 820.100(a)
  • 21 CFR 820.22
  • 21 CFR 820.90(a)
  • 21 CFR 820.20(c)
  • 21 CFR 830
  • 21 CFR 890.5500
  • 21 CFR 890.9
  • 21 CFR 890.9(a)