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FDA Warning Letter Action Package

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Dealing with US FDA Warning Letters

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  • 1. Action Package
  • 2. Compliance Insight, Inc. has people with practical, hands-on experience who can effectively and decisively resolve FDA Warning Letter issues. Weve worked together as a team to compile an Action Package for your use in dealing with FDA Warning Letters.
  • 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. 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. Questions? Comments? We are happy to help you! Call us at 513-860-3512 www.Compliance-Insight.com Email: [email protected]

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