Terragene S.A.
2 extracted findings
FDA source excerpt, selected passage
Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit (21 CFR 820.198(a)(b)).
FDA published a close-out letter on Jun 28, 2024. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit (21 CFR 820.198(a)(b)).
Source passage selected by the model
02
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.