The Second Annual Medical Devices Regulatory, Reimbursement and Compliance Congress

1
The Second Annual Medical Devices Regulatory,
Reimbursement and Compliance Congress

• How to Respond to a Corporate Warning Letter
• John M Taylor
• Divisional Vice President for Federal Government
  Affairs

March 30, 2007
2
Background What is a Corporate Warning Letter?

• A Corporate Warning Letter means that
• FDA has identified serious, systematic problems
  with your corporate quality management systems
  and
• FDA believes that your organization fails to have
  an adequate quality management system.
• In this scenario, the Warning Letter covers at
  least 3 facilities
• Tijuana facility January 2004 Warning Letter
• Paducah facility April 2004 Warning Letter
• Orlando facility September 2004 Warning Letter
• Orlando facility 2005 Corporate Warning Letter

3
How do you respond to the letterMake sure you
understand the breadth and seriousness of FDAs
findings

• Review the findings in the 3 facility related
  Warning Letters
• Review the findings in the Corporate Warning
  Letter
• Review the compliance status and inspection
  history of your other facilities
• Make sure your understand the nature of the
  violations
• Quality Systems Regulations
• Field Action Report Regulations
• Medical Device Reporting Regulations
• Identify the facility specific violations versus
  the corporate wide violations

4
How do you respond to the letterDraft a
comprehensive remediation plan

• The remediation plan should focus on
• Management responsibility and oversight
• Corrective and Preventive Action (CAPA)
• Product Surveillance/Complaint Handling/Medical
  Device Reporting and
• Field Action Decision Making (Patient safety
  first).
• The remediation plan should also focus on
• Substance
• Comprehensive, Systemic fixes
• Putting your remediation commitments into a clear
  prioritized order
• Establishing realistic meaningful milestones and
• Achieving compliance quickly and comprehensively.
• The remediation plan must demonstrate to FDA
• That you recognize the breadth and seriousness of
  the violations and
• That despite past failures, you are prepared to
  achieve corporate wide compliance.

5
How do you respond to the letterEstablish good
lines of communication with FDA

• Upon receipt of the Corporate Warning Letter,
  immediately request a face to face meeting with
  FDA
• Make sure that ORA HQ, the relevant Centers, and
  the relevant Districts are in attendance
• Present to FDA your planned commitments and
  timing of completion
• Establish who your key FDA contact will be
• Integrate FDAs comments into your remediation
  plan
• In addition to meeting with FDA, make sure you
  respond to the Corporate Warning Letter (15
  working days) and
• Maintain ongoing communications with FDA during
  the pendency of the remediation process If
  problems arise, notify FDA immediately.

6
How do you respond to the letterFollow through
on your commitment to achieve compliance

• Implement your remediation plan immediately
• Make meaningful measurable progress towards
  fulfilling your commitments
• Be prepared for each follow-up inspection
• Achieve comprehensive corporate wide compliance
  and
• Demonstrate that documented violations are not
  likely to recur in the future.