Topic: FDA warning letter
The FDA has issued a warning letter to a Florida CMO that it says has dirty equipment, poor storage methods and questionable record keeping.
The FDA has slapped a Teva plant in Florida with a warning letter for issues that have affected the dosing of a schizophrenia drug.
Pfizer is responding to a demand from a U.S. Attorney's office for records on EpiPens it manufactured for Mylan that failed during emergencies.
FDA Commissioner Scott Gottlieb, M.D., again turned to Twitter to defend the quality of the U.S. drug supply and the agency’s record of keeping it safe.
Just days after bad news about manufacturing wreaked havoc with Dr. Reddy’s shares, the drugmaker was able to report something positive.
Drug wholesaler McKesson was lashed in an FDA warning letter for shipments in which opioids had been replaced by OTC drugs.
Takeda pulls an FDA filing for Ninlaro and is ordered to pay $155 million in a Shire patent case; a cancer startup gets Chinese investors' attention.
The FDA in 2017 ripped Indian drugmaker Lupin’s Indore plant for repeating mistakes. In a new visit, the FDA has again found problems.
The American Hospital Association has crafted a lengthy list of suggestions for addressing drug shortages that include both the carrot and the stick.
FDA slaps Akorn with warning letter following an inspection of its sterile injectables plant in Illinois.