FiercePharma19h
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
MassDevice23h
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
Food Safety News22d
FDA issues warning letters over allergen labeling failures and sanitation concerns
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 ...
The Hill19d
FDA warns companies over unapproved weight loss drug sales
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 ...
Food Safety News15d
Salmonella outbreak tied to pet food spurs FDA warning letter over facility failures
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Labroots7y
Data Integrity and the FDA Guidance
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 ...
Newsweek19d
FDA Issues Vet Letter on Drug Librela Used to Control Pain in Dogs
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 ...