In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.

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 ...

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 ...

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 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 ...

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.

Zoetis' statement notes that the FDA's action is not a "warning," but is a "'Dear Vet' letter which serves as a safety update." Librela works by blocking the pain pathway from the joint to the ...