On December 17, 2024, the FDA published five (5) warning ... for example, a license to manufacture and distribute them from the drug companies that do. Ultimately, as FDA explains in the letters ...
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 ...
The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...
After thousands of complaints about complications, the FDA has issued an open letter to veterinarians to be alert to serious ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
JonesResearch says shares of Capricor Therapeutics (CAPR) saw some volatility over an FDA warning letter issued to an ... the firm believes the negative response was an overreaction.
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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