MasterControl quality and compliance expert Walt Murray presents what needs to happen in the wake of a U.S. Food and Drug Administration (FDA) inspection. He covers what you need to do to respond to the observations and how to avoid more serious action.
After the inspection, you need to respond to the findings within 15 days. This response should include your plans to correct any issues and timelines for when that will happen. Walt covers general trends in FDA inspections for the past six years and important takeaways from the information from 2014.
Walt discusses how inadequate response to the 483 can lead to a warning letter or more serious action from the FDA. He covers who’s responsible for what and who should be involved in the response process. He helps viewers understand their responsibilities and what to expect from the FDA in the process.