According to the news release:
"Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action."
Read the full news release: FDA Denies Authorization to Market JUUL Products - FDA.gov
"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."Apparently in an FDA Warning Letter to Teva early this year, the FDA is telegraphing their desire to see these kinds of elements in a response:
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According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .
The draft guidance also recommends that:
The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.
Related Posts: FDA Struggles To Keep Products From Foreign Sources Safe FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants
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Not my usual kind of post, and for some reason this caught my eye. Perhaps it's because of my microbiology and healthcare training background, and throw in my obsession with cleanliness. I've always just enjoyed and taken for granted, the marvelous cleaning power of bleach. Until now, I've never stopped to consider, "How Bleach Kills Bacteria." This Medical News Today report is fun to read as it . . .
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