The FDA has banned products from a Chinese API maker and suggested it get a consultant to direct upgrades after an inspection found serious problems in its manufacturing processes, some of which had been uncovered in two earlier inspections.
Yicheng Goto Pharmaceuticals was issued a warning letter after inspectors uncovered manufacturing and testing issues at its plant in Yicheng City in Hubei Province during a visit last year. In January, the FDA placed the API maker on its import alert list.
The FDA said the company was not properly testing for API stability and could not even show that it was reliably manufacturing products that met their predetermined quality attributes. On top of that, the FDA had problems with how the company was cleaning its equipment between production runs to prevent cross contamination.
The findings in September 2017 came after similar issues were noted at the plant during inspections in 2011 and 2014.
There is greater attention on Chinese API makers right now after Zhejiang Huahai Pharmaceutical last month set off a global recall of blood pressure drugs containing valsartan because its API was found to contain N-nitrosodimethylamine (NDMA), an impurity that might cause cancer. The company said the impurity appeared to be the result of a manufacturing change it had made.
Huahai Pharmaceutical said that after making its discovery it had suspended manufacturing and supply of valsartan, sealed its unshipped batches and informed customers and regulators, including the FDA. It said that while no regulatory agency has currently placed restrictions on NDMA, it was working with regulators to set an industry standard. With a reported 45% market share, the Huahai API turned up in many generic products. It is unclear why its products were used in U.S. meds given that its APIs were placed on import alert in January 2016.
As with Goto, the FDA had twice before inspected Huahai Pharmaceutical’s plant in Linhai, China, with the most recent visit last year. Inspectors found a plant with little regard for quality control. It repeatedly reanalyzed API batches to achieve passing results, even when tests showed a “large differential,” then shipped them to the U.S. without ever investigating why the out-of-spec results occurred in the first place.