Announcing New FDA 483 Response Kit

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Compliance Insight Inc., a leading FDA Consulting Firm, is pleased to announce the release of their new FDA 483 Response Kit for Pharmaceutical and API Firms.

Compliance Insight Inc. announces the release of their new FDA 483 Response Kit. Pharmaceutical firms now have a simple guide for understanding and responding to FDA 483 observations.

According to the FDA, over 5,700 FDA 483 letters were sent out in 2012. It is important for a company who receives a FDA 483 to skillfully respond to the FDA (and other stakeholders) with a document that clearly and decisively demonstrates the firms understanding, acknowledgement and resolution of the issues.

Unfortunately, many companies lack the skills and experience to properly respond to a FDA 483.

To help companies properly respond to a FDA 483, Compliance Insight Inc. has released on online FDA 483 Response Kit that includes the following:

  •     How To Be Ready For A FDA Inspection
  •     How To Understand Your FDA 483 Observations
  •     How To Respond To Your FDA 483
  •     FDA 483 Response Sample Format
  •     Understanding FDA Compliance

Compliance Insight’s FDA 483 Response Kit is available on the Compliance Insight Inc. website at http://compliance-insight.com/fda-483.

About Compliance Insight Inc.

Compliance Insight offers hands-on compliance, quality assurance, clinical and regulatory affairs guidance and consulting. Compliance Insight Inc.’s services are reliable, accurate, timely and supportive of the client’s goals and compliant with US FDA Regulations.

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Cynthia Ipach, President
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