Some drugmakers get cited for handling manufacturing or testing poorly. Others are cited for refusing to even to let authorities get a look at what they are up to.
Chinese API maker Jiangsu Yew Pharmaceutical, based in Yixing City, China, had its European marketing authorization suspended for refusing to allow Hungarian inspectors into a manufacturing facility during a visit in late June, according to a posting on the European Medicines Agency’s Eudra GMDP website.
Among the products produced at the facility is an active substance intermediate ingredient in temozolomide, which is used in oral chemotherapy drugs designed to treat some brain cancers as well as glioblastoma multiforme and astrocytoma.
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As a result of the company's actions, the EMA is calling for a recall of ingredients produced at the facility. The European Directorate for the Quality of Medicines is also looking at denying approval of the company’s Certification of Suitability.
The company’s export director, Henry Yang, told Reuters the inspection was refused because Jiangsu Yew only made an intermediate product instead of an API, and therefore an audit was not required.
In 2016, the FDA issued a warning letter to Beijing Taiyang Pharmaceutical after initially refusing to let inspectors into its API plant. The letter says that when FDA inspectors first visited the plant in November 2015, they could see through a window of a warehouse numerous drums bearing the company’s label. But employees refused to let inspectors in that day and didn’t have a “reasonable explanation.” When inspectors returned the next day, many of the drums had been removed, but the company had no explanation of why they were gone.
The company also was slammed for “systemic data manipulation” at the facility. Employees repeated batch tests until getting acceptable results and deleted from computers results that didn’t measure up. They didn’t investigate out-of-spec data the company reported, and the company then “relied on these falsified and manipulated test results to support batch release and stability data,” the letter says.