The former China Food and Drug Administration organized to carry out on-site inspections of imported pharmaceuticals for overseas production in Indian Sun Pharmaceutical Industries Ltd. The inspected variety was imipenem and cilastatin sodium for injection (English name: Imipenem and Cilastatin Sodium for Injection; Specification: 0.5 g, 1.0 g; imported drug registration number: H20100699 (0.5 g); H20100698 (1.0 g)).The inspection found that the company failed to effectively control the bacterial endotoxin of above-mentioned varieties, failed to prove the effectiveness of aseptic operations in the production processes, the cleaning method of drug substance reaction tank has not been effectively verified, and other problems of production management and quality management. They were not in line with the requirements of Chinese Good Manufacturing Practice (revised in 2010).The product has a quality risk. 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. The food and drug administrations at all ports will suspend the issuance of customs clearance certificate for the product, and organize the processing according to laws.

It is hereby announced.

China Drug Administration

May 11,2018