[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] An April inspection of a Zhuhai United Laboratories sterile API site in Guangdong, China by Romanian inspectors representing EMA has resulted in some of the firm’s amoxicillin products being banned from sale in the EU. The firm claims to be the world’s largest manufacturer of the API for the antibiotic amoxicillin. According to the inspection report, issues were observed with aseptic manufacturing facilities design, equipment, operations, environmental monitoring and media fill validation. The inspectors state in the report that “the QA system of the company failed to notice these problems and therefore was considered weak and inappropriately implemented.” Zhuhai is the second Chinese API maker that Europe has taken action against this year (see IPQ “News in Brief” March 27, 2015).