On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of ...
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...
Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 ...
The company's response to the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said that the issues raised by the regulator mainly ...
Our plants around the world are regularly inspected by health authorities to ensure compliance with the various markets we serve. Following an inspection by the U.S. FDA at our oral finished dose ...
On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
In a warning letter published Tuesday, the FDA scolded Applied on two counts related to its 47-patient study of govorestat in kids with classic galactosemia. Specifically, agency investigators ...
The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
BD received a warning letter after the Food and Drug Administration found fault with the practices at a facility that manufactures Pyxis medication management system medical devices. The letter ...
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