Absence of a Written Program for Drug Products


Pharmagen Laboratories, Inc
Issued on:
Inspection Dates:
05 Aug 2013 to 23 Aug 2013
30 Buxton Farms Road Suite 110, Stamford, CT 06905
  • Maya M Davis
  • Sharon K Thoma

Detailed Analysis

Key Observations

  • The lack of a change control system and inadequate procedural documentation highlights significant gaps in regulatory compliance and internal quality management systems.

Possible Root Cause :

  • Lack of oversight from the quality unit or relevant organizational units, resulting in the absence of a formalized system for tracking or assessing changes.
  • Insufficient training or understanding of the importance and regulatory requirements for documented procedures among staff.
  • Potential understaffing or lack of resources dedicated to documentation and change management, impacting the ability to develop and maintain such systems.

Corrective Action:

  • Develop and implement a formal change control system, including policies for documenting, reviewing, and approving changes to processes, equipment, and procedures.
  • Conduct comprehensive training for all relevant staff on the importance of documented procedures and change control management.
  • Allocate additional resources or reassign staff to ensure proper development and maintenance of documentation and change management processes.

Preventive Action

  • Establish a periodic review process for change control and documentation procedures to ensure ongoing compliance and effectiveness.
  • Implement a training program for new employees and continual education for existing staff on regulatory requirements and internal procedures related to change management and documentation.
  • Improve communication and oversight mechanisms within the quality unit to ensure timely review and approval of procedures and changes.
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