Imagine you’re a parent thinking about which private school to send your child to. You’re looking at School X and it seems like a great fit; it’s close, inexpensive, great teachers, etc… But as you peruse the school’s website you’re suddenly shocked to find a horrifying statistic. In 2008 the school had 20 students out sick, 40 students out in 2009 and then a whopping 80 students out sick last year! Looks like an epidemic! “There’s no way I’m sending my kid to that sick ward!” Looks like you just made your decision, right? But what’s the missing factor … READ MORE

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The Food Safety Modernization Act (FSMA) enacted January 4, 2011 set forth a variety of benchmark reporting requirements for FDA, one of which is a summary of the FDA’s foreign offices and their progress and direction for the future.  The FDA has recently submitted this report and it gives us a glimpse into the international intentions of FDA.  Being in the FDA Import Regulatory Consultant business, we think that’s kind of useful. FDA’s report discusses the agency’s vision for its field offices, a distinction between “posts” and “offices,” the tasks and activities of foreign posts, the past progress and … READ MORE

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FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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