FDA warning letter action package

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Compliance Insight, Inc.

Dealing with US FDA Warning Letters

Negócios Tecnologia

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.

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

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!!

Questions? Comments?
We are happy to help you!
Call us at 513-860-3512
www.Compliance-Insight.com
Email: FDAWarningLetterTeam@Compliance-Insight.com

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FDA warning letter action package

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… • • • • 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

FDA warning letter action package

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FDA warning letter action package