Red Flags Raised at Maker of Recalled Heart Drug a Year Ago
- FDA inspector found Chinese company ignored quality failures
- Heart drug was recalled in July for cancer-causing contaminant
This article is for subscribers only.
A U.S. inspector raised concerns with the Chinese manufacturer of a widely used heart drug more than a year before it was recalled for containing a probable cancer-causing chemical.
A Food and Drug Administration inspection in May 2017 found that the company, Zhejiang Huahai Pharmaceutical Co. Ltd., ignored quality testing that showed unnamed drugs didn’t meet U.S. standards, according to an agency report posted online on Thursday. The company didn’t look into the failures, and passing results were recorded instead, according to the report.