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Consumer Device Inspection Readiness

Client Business Situation

A leading high-volume manufacturer of consumer medical devices located outside of the United States was experiencing increased concern regarding their regulatory compliance enforcement profile. Factors contributing to this increasing concern included strong enforcement actions at a sister division and known deficiencies in multiple aspects of the company’s quality systems identified through internal audits and a mock FDA inspection.

Client Business Pain

Client was exposed to significant risk of import cessation of over $250 million dollars of product on an annualized basis due to increased enforcement activity and potential for the FDA to conduct an inspection of the facility within months.

Solutions Provided/Services Delivered

Compliance Architects® provided a Senior Consultant with extensive subject matter expertise in FDA inspection readiness. Activities performed for this client included (but was not limited to):

  • Revision of client’s remediation task list into project-oriented 30 day plan with program management framework to ensure completion of activities on time;
  • Management of revised remediation program to achieve remediation objectives;
  • Development of enforcement history commitments’ matrix outlining historical regulatory commitments and documenting actions and documents responsive to commitments made;
  • Drafting and implementation of major revisions to CAPA and Validation procedures/systems;
  • Training of company Subject Matter Experts on inspection conduct and preparation;
  • Drafting and coordination of inspection readiness action plan to ensure company readiness prior to notified inspection date.

Benefits Realized

Following a full week’s FDA inspection six months after Compliance Architects® arrived onsite, the client received no Form 483 resulting from the inspection. The client’s supply situation was stabilized preserving over $250 million dollars in annualized revenue.

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Case Study

  • Client References
    CA-JM01
  • Product Classes Manufactured
    Medical Device
  • Number of Employees
    600+
  • Number of Client Sites
    1
  • Operating Scope
    Global
  • Annual Revenue
    Approximately $250 million +

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  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • 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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