MassDevice17h
Outset Medical resolves FDA warning letter
Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.
Outset Medical announces resolution of FDA warning letter
Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...
FDA clears Outset Medical of previous warning issues
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
FiercePharma2d
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
Elanco Reinforces Commitment to Veterinary and Pet Owner Education
Elanco Animal Health Incorporated issued the following statement regarding its commitment to clear veterinary and pet owner ...
Food Safety News11d
FDA warns seafood companies over HACCP violations and potentially adulterated products
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Food Safety News4d
FDA warns two companies over foreign supplier verification violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
STAT7d
Lawmakers ask FDA to review Hims’ Super Bowl ad for ‘misleading’ patients
Two senators wrote to the FDA Friday about the Hims Super Bowl ad, which they said misleads patients about compounded weight ...
The Pharma Letter7d
US FDA issues more warning letters to Asian producers
The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...