Non-Compliance with Established Laboratory Controls


Emergent Manufacturing Operations Baltimore LLC
Issued on:
Inspection Dates:
09 Apr 2020 to 20 Apr 2020
5901 E Lombard St, Baltimore, MD 21224-6824
  • Marcellinus D Dordunoo

Detailed Analysis

Key Observations

  • The inadequacy in documenting findings and follow-up actions for complaint investigations suggests a need for strengthening the complaint management process and enhancing the quality assurance oversight.

Possible Root Cause :

  • Lack of a systematic and comprehensive complaint investigation process.
  • Inadequate procedures or training for documenting the findings and follow-up actions for complaint investigations.
  • Ineffective quality oversight in reviewing and approving complaint investigations and their documentation.
  • Potential gaps in the complaint handling procedure which may not clearly define criteria for thorough investigation and documentation requirements.

Corrective Action:

  • Revise and strengthen the complaint handling and investigation procedure to include specific requirements for documenting findings, conclusions, and follow-up actions for each complaint.
  • Implement a complaint investigation documentation template or form that prompts for all necessary information including investigation findings, root cause analysis, corrective and preventive actions, and follow-up activities.
  • Conduct training sessions for relevant employees, especially those involved in complaint handling and investigation, to ensure understanding and adherence to the improved complaint documentation process.
  • Establish a quality review process for all complaint investigations to ensure thoroughness and adequacy of the investigation and appropriateness of follow-up actions before closing out the complaint.

Preventive Action

  • Establish periodic audits of the complaint handling process to ensure compliance with the documented procedures and adequacy of the investigations and follow-up actions.
  • Integrate a continuous improvement feedback loop into the complaint handling and investigation process to identify and address systemic issues or recurring themes in complaints.
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