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FDA warning letter action package


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Dealing with US FDA Warning Letters

Published in: Business, Technology
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FDA warning letter action package

  1. 1. Action Package
  2. 2. Compliance Insight, Inc. has people with practical, hands-on experience who can effectively and decisively resolve FDA Warning Letter issues. We’ve worked together as a team to compile an Action Package for your use in dealing with FDA Warning Letters.
  3. 3. The FDA Warning Letter Action Package • Example FDA Warning Letters and responses • Template for the response • A complimentary one hour discussion with our experts on your particular situation • Template cover page
  4. 4. Some complimentary advice… • • • • Have someone, not directly involved with the response, review it Seek council with the FDA to directly discuss your actions Management should follow-up with progress of commitments Be prepared for a follow-up audit • Bottom line – control your processes!!
  5. 5. Questions? Comments? We are happy to help you! Call us at 513-860-3512 Email: