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IMPROVE FDA Enforcement Responses & Action Plans

Uh oh – so you received an FDA-483 or Warning Letter.   Don’t despair – you can still resolve your FDA enforcement issues without significant risk to your company.   Be clear though:  responding to FDA enforcement actions is one of the single most important activities a Quality executive can perform.   Development of comprehensive responses to these significant events can dramatically reduce the risk of follow-on enforcement.

However, just responding is not enough.

Comprehensive Responses /
Aggressive Remediation Execution

Comprehensive FDA enforcement responses must be combined with exceptional remediation planning and execution.   Program execution requires the ability to integrate FDA quality systems and compliance expertise under an umbrella of rigorous project and program management, to ensure commitments are strictly monitored and deliverables accomplished.  Some consulting firms audit.   Some simply give advice.  Compliance Architects® is uniquely positioned to provide the counsel, strategy, leadership, expertise, hands-on resources and delivery capability to help you respond to enforcement actions and comprehensively conduct the myriad activities necessary to complete remediation plan commitments.

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DON’T WAIT – If you are in an enforcement response situation,

CALL US at (888) 734-9778

Time is of the essence in an enforcement setting. We can talk on our dime, and help get you going on the path to improvement. Alternatively, for additional information, or to set up a time to talk, please contact us with the form below.

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  • About Us
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    • Why Us
    • Mission And Vision
    • Clients
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    • 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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