Yuki Gosei Kogyo on Health Canada Inspection List Due to Failed General GMP observations
The US Food and Drug Administration (FDA) on Monday released five Form 483s sent to manufacturers in India, Japan and the US either because they had been frequently requested or because FDA wanted to proactively post the reports.
Yuki Gosei Kogyo Receives FDA Warning Letter
For the past 3-4 years, the topics data and data integrity have been moving into the focus of FDA inspections. Recently, Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd. received a warning letter referring to this. The inspection took place between 13 and 17 November, 2017; the warning letter was published on 17 July, 2018.
Analysts are worried that Takeda's lack of up-and-coming assets is more problematic than the Velcade decline. GlaxoSmithKline is closing a Bangladesh plant and laying off 1,000 as it streamlines emerging markets operations. Laekna obtains Novartis' cancer drugs afuresertib and uprosertib.
Yuki Gosei Kogyo Receives FDA Warning Letter
Japanese Firm Shows Pattern of Unreported Lab Data on Released API Lots, FDA Warns A Tokyo-based manufacturer of active pharmaceutical ingredients (APIs) failed to report all laboratory testing data on released lots, according to a warning letter from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).