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The FDA’s Weak Drug Manufacturing Oversight Is a Potentially Deadly Problem

Current manufacturing oversight in the United States and overseas is hampered by staff shortages and limited funding

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Adrian Hernandez
C. Michael White
Wed, 08/04/2021 - 12:01
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T

he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.

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But over the past few years, tens of millions of doses of prescription and over-the-counter drugs have failed FDA quality expectations. This includes the ongoing 2018 recall of thousands of batches of popular blood pressure, diabetes, and acid reflux medications containing the probable carcinogen NDMA.

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