Risks to Sterile Product Due to Inadequate Airflow


Medical Center Pharmacy, Inc
Issued on:
Inspection Dates:
09 Mar 2020 to 09 Apr 2020
2401 N Ocoee Street, Cleveland, TN 37311-3853
  • June P Page
  • Demario L Walls

Detailed Analysis

Key Observations

  • The observation uncovers a critical failure in the firm's quality assurance mechanisms, highlighting inefficiencies in the database management system that could have a sweeping impact on product quality and patient safety. Immediate and strategic actions are necessary to address the backlog of reports and prevent such accumulations in the future.

Possible Root Cause :

  • The significant number of open reports suggests a systemic issue in the database management and follow-up process, possibly due to inadequate staffing or training on the urgency and methodology for closing reports.
  • Potential failures in the process for evaluating the impact of deviations, complaints, and other issues on product quality and manufacturing processes.
  • Lack of defined timelines or accountability measures for the completion of investigations and implementation of necessary actions.
  • Possible technological limitations or flaws within the (b)(4) database system hindering efficient management and tracking of issues.

Corrective Action:

  • Review and assess all open reports immediately to determine their impact on product quality and take necessary remedial actions.
  • Implement a triage system for prioritizing issues based on their potential impact on quality and compliance.
  • Enhance training programs to ensure that all relevant personnel understand the importance of timely investigation closure and are trained on the use of the (b)(4) database for efficient issue management.
  • Increase staffing or reallocate resources as necessary to manage the workload effectively and ensure timely closure of reports.
  • Review and optimize the (b)(4) database system and procedures to identify and rectify any technological or procedural bottlenecks.

Preventive Action

  • Establish stricter oversight and periodic audits of database management practices to ensure compliance with SOPs.
  • Introduce regular training updates and competency assessments for staff involved in deviation management, complaint handling, change control, and CAPA processes.
  • Implement a dashboard or real-time tracking system to provide visibility into the status of all reports, facilitating early detection of delays.
  • Revise SOPs to include clear timelines and accountability for closing reports and taking corrective/preventive actions.
  • Establish a continuous improvement plan for the database system to ensure it evolves with the organization's needs.
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