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 ...

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 ...

Has your company received an FTC warning letter or a penalty offense notice? If so, such correspondence should not be ignored ...

A Viatris plant in India was issued an FDA warning letter. And more ... The deal comes shortly after Zai Lab reported impressive response data for its DLL3 ADC, ZL-1310, in small cell lung ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under ... Group has yet to provide a written response addressing the observations.

Days after the FDA complete response letter, the FDA sent Applied a warning letter. The trial and the drug are redacted in the public version of the letter, but in a regulatory filing, Applied ...

Senate Republican Leader Mitch McConnell issued an apparent warning ... 2023 letter responding to the polio petition, the agency's top vaccine official, Dr. Peter Marks, wrote that the FDA ...