Surviving the Wrath of FDA - Avoiding FDA Criminal Liability for Failing to Comply with FSMA

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

The FDA is using criminal prosecution as a tool to ensure compliance with the FSMA. Learn how to protect your rights during the course of an FDA inspection or investigation.

The FDA’s expansive new powers under the Food Safety Modernization Act (FSMA) have made the agency increasingly aggressive during its food safety inspections and investigations. Using criminal prosecution as a tool to ensure compliance with the FSMA, the FDA has demonstrated its willingness to go after food company executives and employees in a number of high-profile cases. At the same time, the FDA has granted itself almost limitless power to gain access without a warrant to virtually any company record during the course of an inspection or investigation. Is your company prepared to handle a visit from the FDA?

Join expert speaker Shawn Stevens in this 60-minute audio session, which will help you learn about the reach of the FDA’s new powers, recent cases in which it has issued criminal charges, the standards under which you or your company can be criminally prosecuted by the FDA, and how to protect your rights during the course of an FDA inspection or investigation.

Session Highlights:

  • The FDA’s expansive new powers to enforce the FSMA
  • The FDA’s power to go through your company’s records and computers
  • The FDA’s power to criminally charge food companies and employees
  • Recent cases in which food company executives and employees have been prosecuted by the FDA
  • How to prepare your facility and employees for your next FSMA inspection
  • How to correct conditions in your facility that can lead to criminal prosecution
  • How to protect yourself from a criminal prosecution

Agenda Details:

  • FDA regulatory requirements for protecting public health
  • Criteria used by the FDA to identify organizations to inspect
  • The scope and impact of the FDA’s increased powers
  • The FDA’s purview under routine inspections
  • The FDA’s access to company records
  • The FDA’s expanding scope for enforcement
  • A detailed look at the Park Doctrine, or the responsible corporate officer doctrine
  • Recent examples of FDA enforcement of criminal felony charges

Who Should Attend?

  • Food company owners and high-level executives
  • Corporate food safety directors
  • Quality assurance managers

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About Our Speaker

Shawn K. Stevens - Food Safety Auditor

Shawn K. Stevens is a food safety lawyer and founding member of Food Industry Counsel LLC, the only law firm in the nation that represents the food industry exclusively.

For more than a decade, Mr. Stevens has worked nationally with food industry clients (including the world’s largest food processors, national restaurant chains, and food distributors and grocers) helping them protect their brand by proactively...   More Info
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