The Washington Post has reported that a Food and Drug Administration (FDA) 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.
Reporter Anna Edney said During an inspection in May 2017, it was found that the company, Zhejiang Huahai Pharmaceutical Co. Ltd., ignored quality testing that showed unnamed drugs didn't meet American standards, according to an agency report.
The company didn't look into the failures, and passing results were recorded instead, according to the report.
The blood-pressure medicine, called valsartan, was recalled last month, including in South Africa, where the South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, recalled certain medications containing valsartan and are currently reviewing the recalled medicines.
Last month it was announced that the following medicines containing valsartan (produced by Zhejiang Huahai Pharmaceuticals in China) are being recalled by Pharma Dynamics in collaboration with SAHPRA.
- Dynaval Co 80/12,5 mg (tablet); registration number: 44/7.1.3/0018
- Dynaval Co 160/12,5 mg (tablet); registration number: 44/7.1.3/0019
- Dynaval Co 160/25 mg (tablet); registration number: 44/7.1.3/0020
The recall is in line with an international recall of medicines containing the active substance valsartan, supplied by Zhejiang Huahai Pharmaceuticals. It came after the detection of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan-containing medicines.
NDMA is classified as a probable human carcinogen - a substance that causes a normal cell to change into a cancerous cell.
The Washington Post also reported that the FDA also added valsartan made by India-based Hetero Labs Ltd. to the recall. The chemical in the Hetero valsartan exceeds acceptable levels, though is generally lower than levels found in the active ingredient made by Zhejiang Huahai. The Hetero products are labeled under Camber Pharmaceuticals Inc. An FDA inspection uncovered problems at Hetero in 2016.
Hetero's manufacturing process is similar to Zhejiang Huahai's, and the FDA has contacted other valsartan makers to determine if their manufacturing processes are at risk.
The FDA has found issues related to drug manufacturing in China and India that have raised concerns about the safety of those pharmaceuticals.
More than 80 percent of the ingredients used to make U.S.-consumed drugs are produced outside of the country, according to the agency. China, along with India, accounts for most of the raw ingredients in drugs consumed in the U.S.
The FDA redacted from the Zhejiang Huahai report the names of the drugs that failed quality testing, but the report indicates that the tests were on active pharmaceutical ingredients. Zhejiang Huahai made active ingredients for the drug valsartan, which treats heart failure and high blood pressure and is sold by Teva Pharmaceutical Industries Ltd. and Prinston Pharmaceutical Inc. Those companies recalled the products last month.
The valsartan that was recalled contained a chemical called NDMA, which the U.S. Environmental Protection Agency considers a probable human carcinogen. Based on manufacturing records, NDMA may have been in the impure valsartan for as long as four years. The FDA is testing samples of valsartan to determine the extent of the contamination.
During impurity testing, Zhejiang Huahai ignored indications of potential problems but they weren't investigated, the FDA inspector found last year, the report said.
FDA inspectors comb through computer files at drug manufacturing companies to examine the integrity of their testing processes. They also inspect equipment used to make the drugs. The report posted on Thursday found Zhejiang Huahai machines in disrepair.
The inspection covered Zhejiang Huahai's Chuannan factory in Linhai. Danish authorities have confirmed valsartan's active ingredient was made in the Linhai factory in the town of Duqiao where the 2017 FDA inspection covers.
The company also has a factory in Xunqiao that the FDA inspected in November 2016. The FDA found workers didn't follow all procedures meant to prevent contamination and hadn't established proper controls to ensure drugs met U.S. standards for strength, quality and purity.
It's unclear if the valsartan active ingredient was also made at the Xunqiao plant. Pharmaceutical companies aren't required under U.S. law to reveal which drugs they make at which factories. They also can protect as a trade secret where they obtain active an ingredient so Americans don't typically know where their drug's contents are made unless a major recall necessitates the companies reveal the information.
After each inspection, the FDA told Zhejiang Huahai it needed to voluntarily make corrections to its manufacturing practices.
The Washington Post reported that Zhejiang Huahai didn't respond to requests for comment.