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Content by Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
When Inspections and Regulations Leave Quality Lacking, Try ThisA Case for Quality is changing medical device manufacturers focus and FDA’s approach
Wed, 12/02/2015 - 16:33
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified…
Regulators Caught in the Act of Protecting Public HealthFDA field inspectors take quality control with them
Wed, 12/24/2014 - 00:00
  We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live…

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