Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were sent to companies located in the US, Argentina, China, Europe, India, and the Philippines and included manufacturers of drugs, medical devices, and cosmetics.
More than half of the warning letters were sent to manufacturers of medical devices, “which were repeatedly accused of not processing complaints properly.” In addition to medical device companies, FDA’s warning letters cited various companies for a number of different violations, including, but not limited to, the following:
Quality and compliance violations are among the most serious issues faced by drug makers. As such, FDA does not take them lightly. It is important to approach each project with consistency and accuracy in order to avoid issues involving the quality of your products. Sometimes, despite your best efforts, you may still run into these or similar violations. In these circumstances, you need to respond quickly and appropriately to avoid further regulatory action.
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