Taiwanese API maker abandons U.S. market rather than concede to FDA

A large sign indicating the location of the U.S. FDA building

Most drugmakers readily agree to invest in plant upgrades if the FDA cites them for violations so they can keep selling products into the U.S., the world's largest pharma market. But not KO DA Pharmaceutical. When FDA inspectors found issues during a recent inspection, the Taiwanese API maker decided to quit shipping products to the U.S. rather than change its production.  

According to warning letter posted by the FDA this week, inspectors were in the KO DA Pharmaceutical plant in Taoyuan City in late May. An inspection led to four observations including the fact the plant had no written procedures for production and process controls or for the preparation of master production and control records to assure batch uniformity. The quality control unit was not approving the production procedures that the company uses.

But the FDA said that KO DA officials wouldn’t commit to making any corrective actions and instead indicated KO DA would quit shipping to the U.S. the one product that it was selling there. The agency said if the company changes its mind, that it should consider hring a consultant help it figure out FDA regs and put procedures in place to meet them.

The FDA found similar issues at another Taiwanese drug plant in 2013. In that case, the FDA issued a warning letter to Three Mast Pharmaceutical in Tainan City for having no written procedures for production and testing.

The Republic of China has found issues itself among some drugmakers and even within its own drug regulating agency. Last year, a Taiwan FDA plant inspector was arrested and charged with taking more than $150,000 in bribes to pass info on upcoming pharmaceutical inspections to drugmakers in the country.

- here’s the warning letter 

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