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

Terragene S.A.

Issued · Posted by FDA

FDA published a close-out letter on Jun 28, 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 establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit (21 CFR 820.198(a)(b)).

Passage 2

Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

Citations in the original letter

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

  • 21 CFR 803
  • 21 CFR 803.17
  • 21 CFR 807.81(b)
  • 21 CFR 820.198(a)(b)