On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.

This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.

This audio conference covers:

• FDA's plan to dramatically increase the number and frequency of inspections
• An overview of FDA Form 483
• Actions during an FDA inspection
• The "hot list" items likely to get extra attention from FDA inspectors
• How to properly respond if FDA issues your company a Form 483
• The implications of not responding

About the speaker:

Lisa Capote is a partner and leads the Food & Drug Practice Team of Arrastia & Capote, LLP. She focuses her practice on representing clients before regulatory agencies, such as the Food and Drug Administration and Customs and Border Protection. Her representations have ranged from publicly traded companies to small businesses and individual business people. She has successfully removed companies from FDA’s Import Alerts, assisted with registration and compliance under the Bioterrorism Act of 2002, and participated in FDA investigations as well as drafting responses to Form 483. She is a member of the Florida Bar, US District Court Southern District of Florida, and the Florida Customs Brokers & Forwarders Association, Inc. She received her Bachelor of Science in Business Administration and her Juris Doctorate from the University of Miami, School of Law. She has presented for America’s Food and Beverage Show and other international organizations on FDA related topics.

Who should attend?

• Regulatory Compliance
• Quality Assurance
• Risk Management
• Legal Counsel
• Senior Management