Dealing with US FDA Warning Letters

1. Action Package

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. 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…
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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: FDAWarningLetterTeam@Compliance-Insight.com