Topic: FDA warning letter
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
The FDA served a warning letter to China’s Wuxi Medical Instrument Factory in response to an inspection that exposed four violations.
South Korean drug manufacturer Firson was slapped with a warning letter and placed on an import alert by the FDA.
The FDA has sent its third warning letter in three months to facilities making homeopathic meds, raising concerns about potentially toxic ingredients.
Takeda and AZ will team up on Parkinson’s candidate, Samsung Bioepis got nod for a Humira copycat and Daiichi Sankyo said AZ buyout is “not the fact.”
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document disaster at its API plant in Ahmedabad. Now the agency has taken the step of banning all of the company’s products produced at the facility.
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
The worst is over for a CordenPharma sterile manufacturing plant in Italy that was slapped last year with an FDA warning letter.
Zai Lab filed for a $115 million Nasdaq IPO, Takeda formed an R&D deal with Stanford, Fosun and Shanghai Pharma aim to buy a stake in Arbor, and more.
The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.