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The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw
Glenmark Pharmaceuticals issued seven recalls for pills that didn’t dissolve properly, records show. All were made at the same factory in India. But the FDA still hasn’t stopped the company from shipping other pills made there to the U.S.
Fed up with what they called “institutional weaknesses and dysfunction” in the oversight of foreign drugmakers, the House Committee on Energy and Commerce in June demanded that the head of the FDA turn over documents about inspections in India and China. Overseas compliance with U.S. manufacturing standards is crucial in a drug market where foreign factories like the ones operated by Glenmark make a wide range of injections and pills that treat some of the most vulnerable patients in the U.S., including those with cancer, heart disease, epilepsy and kidney ailments. That spring, FDA investigators went to the company’s Himachal Pradesh plant in northern India and reviewed more than 100 complaints about products made there: A steroid cream was gritty, a medication was watery, and tubes of medicines were cracked and punctured.
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