Failure to adequately address observations from an FDA inspection can lead to serious consequences, including warning letters; regulatory meetings; import alerts; seizures of products and operational shutdowns.
Responding appropriately to the FDA can mean the difference between continuing operations without interruption and increased regulatory oversight. The purpose of this presentation is to address what you should do after an inspection to assure the FDA properly evaluates your response and corrections to observations. The webinar will provide insights into what happens at FDA after an inspection and how you can protect your company from adverse actions by the FDA.
The webinar will answer the following questions:

1. What is a FDA-483?
2. What happens in the FDA after an inspection?
3. What are the possible adverse outcomes from an inspection?
4. Why respond to an FDA inspection?
5. How does the FDA determine the action it takes after inspections?

This is the second webinar being presented by Larry Stringer for Registrar Corp. The first webinar addressed what happens during FDA inspections. This webinar will address FDA 483 observations and how to respond to them, what FDA does following an inspection and how it decides to take action.

Larry spent more than 30 years working for the US Food & Drug Administration. Larry is regarded as an expert on FDA inspection, sampling and investigation procedures. Larry conducted hundreds of FDA inspections, oversaw significant investigations, and worked with other federal agencies during National Special Security Events. He led a team that revised and updated FDA’s Investigations Operations Manual (IOM). The IOM is the main reference and guidance for field investigators and provides detailed procedures and instructions for how FDA conducts its field operations. Internally at FDA, Larry was considered an expert on the inspection process, collection of evidence and sample collection. Larry is now an independent contractor with Canal Row Advisors.