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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Vitang Technology LLC

Issued · Posted by FDA

FDA published a close-out letter on Jul 31, 2024. The passages below are from the original warning letter.

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 receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198.

Passage 2

Failure to validate software used as part of the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i).

Passage 3

Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).

Passage 4

Failure to adequately establish and maintain procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).

Passage 5

Failure to establish procedures for device history records as required by 21 CFR 820.184.

Passage 6

Failure to document the results and/or dates of management reviews as required by 21 CFR 820.20(c).

Passage 7

Failure to document personnel training as required by 21 CFR 820.25(b).

Citations in the original letter

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

  • 21 CFR 807.81(a)(3)
  • 21 CFR 807.81(b)
  • 21 CFR 807.97
  • 21 CFR 820.30
  • 21 CFR 820.198
  • 21 CFR 820.70(i)
  • 21 CFR 820.50(a)
  • 21 CFR 820.75(b)
  • 21 CFR 820.75(a)
  • 21 CFR 820.72(a)
  • 21 CFR 820.184
  • 21 CFR 820.20(c)
  • 21 CFR 820.25(b)