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 ...
FiercePharma20h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
MassDevice1d
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.
Integra LifeSciences Gets FDA Warning Letter Regarding 3 Facilities
Integra LifeSciences Holdings said a subsidiary received a warning letter from the Food and Drug Administration over issues identified during inspections at three company facilities.
Integra LifeSciences Subsidiary Receives Warning Letter From FDA Related to Quality System Issues >IART
Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...
Food Safety News1d
FDA warns Stew Leonard’s Holdings over misbranded cookie products following anaphylactic death
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...