The former China Food and Drug Administration organized to carry out on-site inspections of imported pharmaceuticals for overseas production in Dr. Reddy’s Laboratories Ltd. in Indian. The inspected variety was Quetiapine Fumarate (registration number: H20160462). The inspection found that the actual production process, production sites, batch volume were inconsistent with the registration and application. They were not in line with the requirements of Chinese Good Manufacturing Practice(revised in 2010). In order to ensure the safety of public drug, we decided to suspend the sales and use of the product in China from now on and organize the processing according to laws. The food and drug administrations at all ports will suspend the issuance of customs clearance certificate for the product.

It is hereby announced.

China Drug Administration

Sep. 4, 2018