Non-Submission of Adverse Event Report to FDA


Edge Pharma, LLC
Issued on:
Inspection Dates:
04 Mar 2020 to 30 Mar 2020
856 Hercules Dr, Colchester, VT 05446-8014
  • John P Mistler
  • Samir C Gala
  • Jonah S Ufferfilge
  • Erik W Koester

Detailed Analysis

Key Observations

  • The facility failed to submit adverse event reports to the FDA as required, demonstrating a gap in their understanding or execution of adverse event reporting procedures and possibly affecting patient safety.

Possible Root Cause :

  • Lack of clear procedures for adverse event reporting.
  • Failure to recognize the importance of reporting serious and unexpected adverse events to the FDA.
  • Insufficient training on adverse event reporting requirements.
  • Inadequate investigation process leading to a conclusion not to report the event to FDA.

Corrective Action:

  • Review and revise the adverse event reporting procedures to ensure they align with FDA guidance and regulatory requirements.
  • Conduct a comprehensive review of past adverse event reports to identify any other incidents that were not reported and submit them to the FDA as required.
  • Implement additional training for staff on adverse event reporting requirements and importance.
  • Enhance the investigation process of adverse events to ensure thorough and unbiased conclusions.

Preventive Action

  • Establish a routine audit process to review compliance with adverse event reporting procedures.
  • Develop and implement a continuous training program on adverse event reporting for all relevant staff, with periodic updates on any regulatory changes.
  • Incorporate adverse event reporting requirements into the quality management system to ensure ongoing compliance.
  • Implement a tracking and documentation system for adverse event reports to ensure accountability and traceability.
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