Pharmaceutical firms now have a simple guide for understanding and responding to FDA Warning Letters. According to the FDA, a Warning Letter will request corrective actions and a written response within a specific period after receipt of the letter, usually fifteen (15) working days. Unfortunately, many companies lack the skills and experience to properly respond to a FDA Warning Letter.
To help companies properly respond to a FDA Warning Letter, Compliance Insight Inc. has released on online FDA Warning Letter Action Package that includes the following:
Warning Letter – How to survive the storm. Step by step how to respond to a FDA Warning Letter Sample FDA Warning Letter Responses Example FDA Warning Letters From Other Companies Certificate for optional complimentary consultation about your FDA Warning Letter Compliance Insight's FDA Warning Letter Action Package is available on the Compliance Insight Inc. website at FDA Warning Letter Action Package.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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