Topic: FDA warning letter
India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi, Gujarat.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
Amgen inked a biosim deal with Simcere, Gilead won a Chinese nod for Sovaldi, and Shanghai Pharma is in talks to buy part of Alvogen.
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.