Non-Compliance with Drug Complaint Handling Protocols


Qualgen, LLC
Issued on:
Inspection Dates:
13 Sep 2022 to 30 Sep 2022
14844 Bristol Park Blvd, Edmond, OK 73013-1891
  • Patty P Kaewussdangkul
  • Margaret M Annes

Detailed Analysis

Key Observations

  • The firm's existing processes for complaint handling are not effectively followed, leading to unresolved complaints and potential oversight of quality issues.

Possible Root Cause :

  • Lack of adherence to standard operating procedures (SOPs) due to insufficient training or oversight.
  • Inadequate complaint management and documentation system.
  • Insufficient resources allocated to the management of complaints, leading to backlog and inadequate follow-up.

Corrective Action:

  • Review and reinforce training on SOP entitled, "Handling of Complaints" for all relevant staff.
  • Implement a more robust electronic complaint management system to ensure thorough documentation and tracking of complaint investigations.
  • Allocate additional resources or adjust staff duties to ensure timely and effective management of complaints.

Preventive Action

  • Develop regular audits of complaint handling processes to ensure compliance with SOPs.
  • Enhance the complaint handling procedure to include specific timelines for each step of the process and escalation protocols for unresolved complaints.
  • Integrate complaint handling metrics into management review meetings to maintain visibility and accountability.
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