Deconstructing Warning Letters and Using Warning Letters to Illustrate FDA Regulations Webinar
Time: 11:30 AM PST | 02:30 PM EST
Duration: 90 Minutes
Instructor: Larry Spears
If FDA Warning Letters are issued to companies to define specific violations for which the Agency has collected evidence and are prepared to pursue enforcement action, if adequate correction is not made. The letters provide specific regulatory language including:
- The appropriate citations in the law, Federal Food Drug and Cosmetic Act (FFDCA)
- Citations in the regulations, Code of Federal Regulations (CFR), Part 21
- Threat language for failure to correct
- The regulatory contact for responses and the response timeframe.
Why Should you Attend:
Warning Letters are publicly available documents that are damaging to a company´s business. They document adverse findings during an inspection or from other review of company records and information including promotional materials and labeling. After issuance, they are:
- Published on FDA´s website
- Regularly referenced in trade journals and newspapers
- Available to any requestor under the Freedom of Information Act
- Used by some competitors as a marketing tool for their own business.
This presentation provides approaches regarding how to reduce the likelihood of receiving a Warning Letter or how to manage the challenges attendant with receiving such Agency correspondence.
Objectives of the Presentation:
- What a Warning Letter is and its various parts
- The regulations referenced in Warning Letters; just US regulations?
- How to evaluate the parts to prepare improved Warning Letter responses
- Successful mitigation and remediation actions to potentially reduce FDA enforcement action after a Warning Letter
- How to create, implement and monitor a quality plan to strengthen the business and minimize regulatory risk