Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under ... required ingredient details. For example, the Florentine Cookies label failed ...

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 ...

The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...

Zoetis' statement notes that the FDA's action is not a "warning," but is a "'Dear Vet' letter which serves as a safety update." Veterinarian technician Justin Jones prepares a syringe with a ...

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 ...