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Medical Device Manufacturer Remediation

The Challenge 

A medical device manufacturer specializing in global solid dose, parenteral, and cellular therapy received a lengthy Form 483 and subsequent Warning Letter addressing the site’s aseptic manufacturing controls and practices, validation methodology, and quality systems.

  • Upon receipt of the 483, Planet Pharma was engaged to hire resources that could conduct a review of open CAPAs addressed during the investigation through a risk-based assessment within two months, as required by the FDA.
  • Planet Pharma was further engaged to bring on talent that could lead and support all improvement work streams.

The Results 

  • Talent placed by Planet Pharma quickly developed a project management structure that would provide visibility and oversight to the entire portfolio for optimized project selection and resource management.
  • These resources also inventoried the client’s existing project management
    processes, measures, quality controls and tools to identify a common set of
    standard practices. Using these standard project management practices, the client can now quickly initiate and deliver successful projects.
  • The client now has a transparent and lean project portfolio governance
    infrastructure where decision-making aligns with strategic goals. Project
    status is now reported to key decision-makers, ensuring the successful delivery of the right results.

The Solution 

While the backlog was initially thought to include 200-300 CAPAs, 1,200 CAPAs were ultimately identified. Despite the unforeseen expansion, Planet
Pharma’s resources supported the additional scope and provided review
within the original deadline provided to the agency.

During the CAPA review, the site received a Warning Letter subsequent to the initial Form 483. Planet Pharma was selected to deliver talent to support them in the following areas:

  • Management Controls
  • Validation
  • Facilities Improvement
  • Equipment Improvement
  • Quality Systems Redesign
  • Supply Chain and Mfg. Systems
  • Backlog Reductions (Investigations, CAPAs, Complaints)