Cincinnati, Ohio (PRWEB) August 02, 2013
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.