Unestablished Procedures for Design Changes


PhotoMedex, Inc.
Issued on:
Inspection Dates:
27 May 2015 to 16 Jun 2015
2375 Camino Vida Roble Ste B, Carlsbad, CA 92011-1556
  • Shaquenta Y Perkins
  • Scott K Zika

Detailed Analysis

Key Observations

  • The firm failed to adequately establish procedures for design change that ensure necessary validation and verification activities are conducted. This oversight can potentially impact product safety, efficacy, and regulatory compliance.

Possible Root Cause :

  • Insufficient procedures for evaluating and documenting the necessity of validation/verification activities for design changes.
  • Lack of clarity in existing procedures regarding criteria for when validation/verification is required following a design change.
  • Inadequate training or oversight in design change control processes, leading to missed validation/verification activities.

Corrective Action:

  • Revise procedures to clearly define criteria for requiring validation/verification activities following design changes.
  • Conduct retrospective review of all recent design changes to ensure necessary validation/verification activities have been completed.
  • Implement training program focused on change control processes, emphasizing the importance of validation/verification for ensuring product safety and efficacy.

Preventive Action

  • Develop and implement a standardized checklist for design change assessments, including mandatory considerations for validation/verification needs.
  • Increase oversight and periodic audits of design change processes to ensure compliance with updated procedures.
  • Include a regulatory assessment in the change control process to evaluate potential impacts on product approvals.
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