O.N. Diagnostics, LLC
2 extracted findings
FDA source excerpt, selected passage
Failure to document procedures for corrective actions and take action to eliminate the cause of nonconformities in order to prevent recurrence, as required by ISO 13485:2016, Clause 8.5.2.
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 document procedures for corrective actions and take action to eliminate the cause of nonconformities in order to prevent recurrence, as required by ISO 13485:2016, Clause 8.5.2.
Source passage selected by the model
02
Failure to adequately document procedures to ensure that purchased product conforms to specified purchasing information and plan the monitoring and re-evaluation of suppliers, as required by 21 CFR 820, ISO 13485: 2016 Clause 7.4.1.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.