Topic: FDA warning letter
The FDA has banned products from a Chinese API maker after an inspection found serious problems in its manufacturing processes.
Former China FDA chief resigns over vaccine scandal; Astellas buys gene therapy specialist Quethera; FDA found problems at valsartan maker Huahai.
The FDA this month issued the Apotex Research Private plant in India a warning letter, its third in four years.
An FDA inspector didn’t have to spend long to discover that a Canadian API maker was failing to meet FDA standards.
A reinspection of Celltrion's South Korea plant resulted in another Form 483, but not a serious one.
Shire could fill Takeda's gap of late-stage assets; GSK lays off 1,000 as a Bangladesh plant nears closure; Laekna gets two Novartis cancer drugs.
The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter for failing to report lab testing data on released lots.
The FDA issued a warning letter to BioDiagnostic International for producing a solution for vaginal use in filthy conditions.
Baxter has been nailed with a warning letter for a plant in India that it got in its $625 million buyout of Claris Injectables.
Biogen and Eisai's anti-amyloid candidate shows promise; Otsuka signs two M&A deals; Samsung BioLogics faces criminal probe over Biogen JV agreement.