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Medical Device Warning Letter Remediation Assistance

Client Business Situation

Client was a long-established manufacturer of class II durable medical devices designed for mobility assistance. Due to challenging competitive and other market conditions, client had made a decision within the last five years to move manufacturing from a domestically-based operation to an overseas contract manufacturer.

Client Business Pain

Significant FDA enforcement action was brought on by a major class II recall. The root cause of the recall was an overseas contract manufacturer’s use of off-grade medical device components in the product’s manufacture without the appropriate change control, design control, or client notification. Client had received a Warning Letter within the last two years and was anticipating a follow-up FDA inspection.

Solutions Provided/Services Delivered

Compliance Architects® performed the following services:

  • FDA mock inspection to assess FDA inspection readiness;
  • Mock inspection gap analysis and recommendations on remediation;
  • Significant CAPA review and re-documentation to ensure solid, well-constructed CAPA files for FDA review; and
  • Development of an enforcement-commitments’ matrix to ensure FDA enforcement commitments were all thoroughly met.

Benefits Realized

At the end of the engagement the client was in a much better position to receive the anticipated FDA inspection. Risks related to poorly-documented CAPAs and enforcement response obligations were significantly mitigated. Gaps identified during the mock inspection highlighting top-tier risk were incorporated into a remediation plan for execution and completion.

Primary Sidebar

Case Study

  • Client References
    CA-EM01
  • Product Classes Manufactured
    Medical Device
  • Number of Employees
    Approximately 50-60
  • Number of Client Sites
    3
  • Operating Scope
    Global
  • Annual Revenue
    $10 million to $15 million estimated

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  • About Us
    • Senior Staff
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  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

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