The U.S. Food and Drug Administration (FDA) has issued a warning letter to a Chinese drug manufacturer for releasing products without performing microbial tests.
Guangzhou Tinci Materials Technology Co. Ltd. Has received the warning letter for releasing products that did not undergo mandatory microbial testing.
Established in 2000, the company develops active pharmaceutical ingredients and over-the-counter drugs. It is located in Huangpu, Guangzhou, Guangdong Province, China.
The company’s facility in northwest of Hong Kong was taken to task for failing to test a batch of products for the total aerobic microbial count and total yeast and mold counts.
In November 2019, the FDA placed the drug manufacturer on an import alert based on violations occurred during an inspection in July 2019.
The FDA investigation found that a production system had multiple dead legs, which could allow biofilms to form.
The investigators also found that the system had corroded pipes, fittings, brackets, valves and tanks. The article was published online in FDA News.