Quality Control Unit Lacks Investigative Authority


Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Issued on:
Inspection Dates:
02 Dec 2019 to 20 Dec 2019
1990 Westwood Blvd Ste 135, Los Angeles, CA 90025-4650
  • Erika V Butler

Detailed Analysis

Key Observations

  • The quality control unit's inability to fully investigate errors related to sterility test failures and customer complaints highlights significant gaps in the firm's sterility assurance and complaint handling processes. This deficiency impacts the firm's ability to ensure the sterility of its products and adequately respond to potential product quality issues, posing potential risks to patient safety.

Possible Root Cause :

  • Lack of clear procedures and guidelines for handling sterility test failures, leading to inconsistencies in performing necessary subcultures and gram staining.
  • Ineffective training and communication within the quality control unit, resulting in missing or incomplete documentation for sterility test results and subculturing actions.
  • The quality control unit lacks authority or resources to enforce standard operating procedures for sterility testing, leading to inadequate investigations and deviations handling.
  • Absence of a robust complaint investigation process, leading to incomplete assessments and failure to identify underlying causes or trends related to product sterility concerns.

Corrective Action:

  • Revise SOPs related to sterility testing and complaint investigations to include specific actions, documentation requirements, and authority levels for conducting thorough investigations and handling deviations.
  • Implement a training program for quality control personnel focused on sterility testing procedures, complaint handling, and the importance of documentation and thorough investigation.
  • Establish a mechanism for the quality control unit to escalate issues that require additional resources or authority to resolve, ensuring proper attention and action are taken.
  • Conduct a retrospective review of all sterility test failures and customer complaints related to sterility and product quality to identify any trends or systemic issues that need to be addressed.

Preventive Action

  • Develop and enforce a comprehensive training program for all personnel involved in sterility testing and complaint handling, ensuring they are competent and understand their responsibilities.
  • Establish a clear and documented escalation path for the quality control unit to obtain additional support or authority when needed, ensuring issues are adequately addressed.
  • Implement a quality metrics tracking system to monitor the performance of sterility tests and complaints resolution, enabling proactive identification and mitigation of potential quality issues.
  • Conduct regular audits of the sterility testing process and complaint investigations to ensure compliance with SOPs and regulatory requirements.
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