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How to Respond to an FDA Inspection (483)

How to Respond to an FDA Inspection (483)

Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.

Preparing for an FDA Inspection

Preparing for an FDA Inspection

Be prepared when (not if) the FDA is at your doorstep for an inspection! This webinar will cover the processes and procedures to have in place to handle any regulatory inspections at your facility, and the set ups, best practices, and tips for personnel throughout the inspection process, ensuring that the inspection goes as smoothly as possible.

How Do I Prevent Getting on an FDA Red List?

How Do I Prevent Getting on an FDA Red List?

Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business. These disruptions lead to lost time, spoiled shipments, and unhappy customers. But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.

A Guide to FSMA 204

A Guide to FSMA 204

A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food Safety Presented by Tim Lombardo and Thomas Bell The final Food Safety Modernization Act rule, the Food Traceability Rule – commonly referred to as FSMA 204 – will...
How Do I Get Removed from an FDA Red List?

How Do I Get Removed from an FDA Red List?

Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.

These disruptions lead to lost time, spoiled shipments, and unhappy customers.

But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.

Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.

What Do I Need to Know About My Testing Lab?

What Do I Need to Know About My Testing Lab?

Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.

These disruptions lead to lost time, spoiled shipments, and unhappy customers.

But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.

Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.