Missing and Ignored Procedures for Handling Drug Complaints

Overview

Company:
Stokes Healthcare Inc. dba Epicur Pharma
Issued on:
09-Oct-20
Feinumber:
3002815949
Inspection Dates:
24 Sep 2020 to 09 Oct 2020
Location:
8000 Commerce Pkwy Ste 600, Mount Laurel, NJ 08054-2211
Investigators:
  • Russell J Glapion

Detailed Analysis

Key Observations

  • The lack of established and followed procedures for processing drug product complaints indicates significant gaps in the quality management system, potentially affecting product quality and patient safety.

Possible Root Cause :

  • The absence of formalized procedures for processing complaints suggests a lack of a thorough quality management system that adequately addresses complaint handling.
  • Potential human factors including insufficient training or awareness about the significance of complaint processing and its link to product quality and patient safety.
  • Inadequate or unimplemented change management processes leading to gaps in updating or maintaining records accurately.
  • Lack of oversight or insufficient resources dedicated to complaint handling might have contributed to complaints not being entered into the Client Notice of Event Report.

Corrective Action:

  • Develop and implement comprehensive written procedures for handling both written and oral complaints about drug products. This should include steps for logging, investigating, resolving, and documenting complaints.
  • Conduct training sessions for all relevant staff on the new procedures, emphasizing the importance of complaint handling in maintaining product quality and patient safety.
  • Introduce a tracking system or software that facilitates timely entry, tracking, and resolution of all complaints received.

Preventive Action

  • Regular audits of complaint handling processes to ensure compliance with established procedures.
  • Continual training programs aimed at reinforcing the importance of an effective complaint management system.
  • Implement a feedback loop from the complaint handling process into the quality management system to allow for ongoing improvement.
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