Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...

The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

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

On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to ...

The FDA warns that certain imported aluminum, brass, and alloy cookware can leach lead into food, posing health risks, ...

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

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

The UK-based firm has issued five Class II recalls for its RX-series analyzers since 2018 for issues related to reagent carryover between subsequent tests.

After thousands of complaints about complications, the FDA has issued an open letter to veterinarians to be alert to serious ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...