(Yicai) July 17 -- Hengrui Pharmaceuticals has pledged to improve its clean production practices after the US Food and Drug Administration warned the Chinese drugmaker that one of its plants in China’s Jiangsu province had failed on-site checks early this year.

Hengrui will bring in experts and third-party agencies to roll out the FDA's recommended improvements and maintain close contact with the US regulator to conclude the matter as soon as possible, a company spokesperson told Yicai yesterday. It received a warning letter from the FDA this week.

The watchdog inspected Hengrui’s manufacturing base in the firm’s hometown of Lianyungang in January and found it failed to comply with current good manufacturing practice regulations. The facility’s design was also inadequate, with insufficient measures were in place to prevent contamination or confusion in areas used for producing sterile products.

The problems noted by the FDA do not affect the quality and safety of Hengrui’s products, the spokesperson noted, adding that the firm’s exports to the United States have not been affected and the warning does not impact its other production sites. After Hengrui has made the necessary changes, the FDA will review them.

The company does not expect the warning to have a material impact on annual earnings either. The Lianyungang factory makes 12 generic drugs that have FDA marketing approval, but they are not the company’s key products, it said. Last year, the plant exported USD12.4 million of medicines, accounting for just 0.4 percent of Hengrui's total.

Hengrui's stock price [SHA: 600276] closed 1.9 percent higher at CNY41.74 (USD5.70) today. The broader Shanghai market fell 0.5 percent.

Editor: Emmi Laine