Tag: section

Are FDA Reinspection Fees An Opportunity?

Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA’s close out of investigations. It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to … Continue Reading

3 New Ways FDA Will Access Your Records and 5 Things You Can Do About It

The Food Safety Modernization Act ("FSMA") significantly expands the FDA’s ability to access a food company’s records. The expanded authority is found in three places in the statute: FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause … Continue Reading

More on the FSMA and the “Tester Amendment”

Earlier this week, I presented a webinar to the American Cheese Society entitled the "Food Safety Modernization Act and Product Liability." A link to the presentation is here. The presentation covered a number of topics and included a discussion of the so-called "Tester Amendment" to FSMA. The "Tester Amendment" in section 103 of FSMA "exempts" … Continue Reading

A Reportable Food Registry Toolkit

This article was first published on August 27, 2010 in Food Chemical News as part of its "On the Front Burner" series. In its first year, the FDA’s Reportable Food Registry has proven itself to be a high-stakes game changer. The ticking of the RFR’s 24-hour reporting deadline forces a company to make snap decisions … Continue Reading
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