Another South Korean drug company has run afoul of the FDA after inspectors determined it had no quality checks in place and was handling manufacturing decisions with its contractor by phone.
The FDA has already banned all products from OTC drugmaker Seindni Co. and last week slapped the Seoul, South Korea drug company with a warning letter.
The steps were taken after an inspection found the company, which has been shipping over-the-counter skincare products to the U.S. without having any documentation to demonstrate that the products are safe and effective.
“You explained to our investigator that you make finished product release decisions over the phone with your contract manufacturer, based on whether test results meet pre-established specifications. You do not have procedures covering your batch release process, and your quality unit lacks documentation to demonstrate acceptability of batch manufacturing and product quality,” the warning letter said.
In recent months, the FDA has cited two other South Korean drugmakers. Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant. A few weeks earlier, Firson was slapped with a warning letter and placed on an import alert after FDA inspectors determined that it had failed to demonstrate the ability of its aseptic processes to prevent microbial contamination, and there was no robust process to sterilize drugs.