nadequate Maintenance of Equipment and Utensils


Downing Labs, LLC
Issued on:
Inspection Dates:
03 Jun 2014 to 16 Jul 2014
4001 McEwen Rd Suite 110, Dallas, TX 75244-5020
  • Stephen D Brown
  • Darla J Christopher

Detailed Analysis

Key Observations

  • Critical insight is the clear gap in established procedures and training for handling level 3 investigations, indicating a systemic issue within the region's approach to compliance and quality control. This highlights the need for immediate corrective and broad preventive measures to ensure regulatory adherence and safeguard product quality.

Possible Root Cause :

  • Lack of established procedures for developing Corrective and Preventive Actions (CAPA) for level 3 investigations.
  • Insufficient understanding or enforcement of the regulatory requirements.
  • Inadequate training or oversight of personnel responsible for conducting level 3 investigations and subsequent CAPA formation.
  • Absence of a structured framework or tools for tracking and documenting level 3 investigations and their resolutions.
  • Poor management commitment towards ensuring compliance and quality control.

Corrective Action:

  • Develop comprehensive procedures to guide the development of formal CAPA for all level 3 investigations.
  • Conduct training sessions for relevant personnel on the importance and methodology of creating effective CAPA for level 3 investigations.
  • Institute a robust tracking and documentation system for all level 3 investigations and their corresponding CAPA to ensure accountability and traceability.
  • Engage in a management review session to reinforce the importance of compliance and quality control, specifically addressing the handling of level 3 investigations.

Preventive Action

  • Establish a regular audit and review mechanism to ensure adherence to developed procedures for CAPA on all level 3 investigations.
  • Incorporate a mandatory review of level 3 investigations and their CAPA in management review meetings to ensure ongoing compliance and improvement.
  • Implement a continuous training program on regulatory requirements and internal procedures for handling level 3 investigations to prevent future oversights.
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