is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Tuesday, April 3rd, 2012. For more details, or to register please visit our site at www.fxconferences.com
When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.
This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.
Showing posts with label Lisa Capote. Show all posts
Showing posts with label Lisa Capote. Show all posts
Thursday, March 29, 2012
Monday, February 6, 2012
Food Industry Update – Responding to an FDA Form 483
is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
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.
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.
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