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You’re far less of a target for warning letters and 483s when you have answers to questions like these. Here’s where to find them.
This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sights in the months ahead.
FDA Device Enforcement: An Analysis of Warning Letter Trends gives you access — and insights — into all device warning letters published in 2011. It maps out specific practices, policy glitches and omissions that triggered everything from quality and marketing citations to MDR reporting violations. Plus, the analysis goes a vital extra step to get you out in front of the FDA’s new target areas, including foreign supplier quality, data trending, medical device reporting and design controls.
Buy now for answers you need now to avoid warning letters down the road, including:
Remember, there are more audits than ever. If you’re targeted, you’ll be facing better-trained inspectors. Now is the time to get 100% clear about compliance hot spots and key actions that can protect you from costly warning letters.
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