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FDA Warns Korean Drugmaker Over Testing, GMP Issues

Posted 03 October 2017 | By Michael Mezher 

FDA Warns Korean Drugmaker Over Testing, GMP Issues

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January.

In a warning letter released on Monday, FDA says the company failed to adequately test its raw materials and finished products to ensure they conformed to appropriate specifications.

"Your firm failed to analyze glycerin raw material from your supplier prior to the quality unit releasing the glycerin for use in drug product manufacturing," FDA writes, noting that the company did not test the lots to see if diethylene glycol (DEG) or ethylene glycol (EG) was present.

"DEG contamination in pharmaceuticals has resulted in various lethal poisoning incidences in humans worldwide," FDA writes, pointing the company to its 2007 guidance on DEG testing.

In response, FDA calls on the company to provide an update on its DEG and EG testing and to conduct risk assessment of its products that contain glycerin that are on the US market.

FDA also says the company failed to establish scientifically sound laboratory controls and lacked adequate written procedures for production and process control.

According to FDA, Dasan released certain products, including a lot of one of its creams, "without testing each active ingredient for identity and strength."

And, FDA says the company failed to show that its microbial limits tests method was fit to detect microorganisms in the presence of its products.

FDA also said the company had "poor control" of its manufacturing processes.

"You did not perform process performance qualification studies, and also lack an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality," FDA writes.

Additionally, FDA says the company's document control processes are deficient, as none of the procedures submitted to the agency following the inspection had sufficient document control and oversight.

"For example, procedures lacked dates, version control numbers, and evidence of quality control unit review and approval," FDA writes.


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