Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...
Among the issues detailed in a Form 483 notice issued by the agency ... the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of ...
According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition of ...
The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...
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, ...
Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 ...
Indoco Remedies said it is in touch with the regulator regarding matter. "We will work with the USFDA to resolve these issues ...
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