The FDA has issued Teva Pharmaceutical Industries a warning letter over the mechanised controls at the company’s facility in China. This letter comes after the FDA inspected the plant in September last year.
Warning letter
Teva, an Israel-based drug company, has confirmed it is in the process of addressing the FDA’s concerns and will respond to them by 1 May. Several deficiencies at the site were referenced, incorporating the production controls, sampling techniques and process.
This warning letter adds to the company’s recent issues with the FDA, which had flagged concerns on Teva’s sterile injectables facility in Hungary last year. These issues will further impact the company’s performance, which has already been planning to reduce operational costs.