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

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

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

Warning letters often are not issued until a company ... At the conclusion of the inspection, the FDA issued a Form 483, Inspectional Observations, to the facility, highlighting the need for ...

Warning letters often are not issued until a company ... Ineffective corrective actions Mid America’s responses to FDA Form 483 Inspectional Observations, issued at the conclusion of both ...

The Food and Drug Administration (FDA) announced in a statement Tuesday that it has sent warning letters to companies selling unapproved weight loss drugs. The letter went to Xcel Peptides ...

According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition 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 ...