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Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs
Key Excerpts from Article on Website of ProPublica


ProPublica, June 17, 2025
Posted: June 25th, 2025
https://www.propublica.org/article/fda-drug-loophole-sun-pha...

In 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant. For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers. Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs. Sun Pharma’s transgressions were so egregious that the Food and Drug Administration [banned] the factory from exporting drugs to the United States. But ... a secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients. The same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India.

Note: For more along these lines, read our concise summaries of news articles on Big Pharma corruption.


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