Deficient Complaint Procedures Impact Drug Safety Evaluation

Overview

Company:
SCA Pharmaceuticals, LLC
Issued on:
20-Oct-23
Feinumber:
3013736415
Inspection Dates:
18 Sep 2023 to 20 Oct 2023
Location:
755 Rainbow Rd Ste B, Windsor, CT 06095-1024
Investigators:
  • Jonah S Ufferfilge
  • John P Mistler

Detailed Analysis

Key Observations

  • The firm's failure to adequately investigate customer complaints and test returned products associated with those complaints indicates a significant deficiency in the complaint handling and quality assurance processes.

Possible Root Cause :

  • Lack of thorough procedures for handling complaints, conducting investigations, and documenting findings.
  • Inefficient process for testing returned products associated with complaints.
  • Insufficient training for employees on complaint handling and investigation procedures.

Corrective Action:

  • Revise current complaint handling procedures to include clear steps for complaint investigation, documenting findings, and decision-making criteria for product testing.
  • Implement a process for testing returned products associated with complaints to confirm or refute complaint validity.
  • Conduct training sessions for relevant employees on the updated complaint handling and investigation procedures.

Preventive Action

  • Establish a periodic review process for complaint handling procedures to ensure they remain effective and compliant with regulatory requirements.
  • Introduce regular training sessions on complaint handling and investigation techniques for new and existing employees.
  • Implement a tracking system for complaints and investigations to monitor effectiveness over time and identify areas for improvement.
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