Korean Device Firm Denies FDA Inspection

A South Korean insulin syringe and pen needle manufacturer on Wednesday became the fifth foreign company to currently have its products banned from entry into the US after denying an inspection by the US Food and Drug Administration (FDA).

Seoul, Korea-based MedExel Medical Manufacturing Co., which manufactures insulin syringes and insulin pen needles in Korea, joined Taiwan’s Morris Engineering Works, India’s Sewa Medicals, and China’s Intop Tech and Shanghai Realov Electronic Technology Co. as the only companies on a list of those that produce FDA-regulated devices for import into the US and yet refused to allow the completion of an FDA inspection to determine facility conditions and compliance with applicable laws and regulations.

The import alert list is updated frequently and often companies are added, like Singapore’s Biosensors International in January, and then removed when they respond to FDA requests.

On its website, MedExel, which was founded in 2000, said it has been inspected by Chinese, Korean and US officials and that it has one of the first mass production facilities in Korea with an automatic manufacturing system that offers “the biggest manufacturing capacity system in Korea.” According to a website of 510(k) application decisions, MedExel won approval for its 510(k) of a syringe in 2005.

The company did not respond to a request for comment.

“If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of an FDA inspection of the foreign facility,” the devices manufactured at that facility are considered adulterated, the agency says.

Import Alert List

Guide to inspections for foreign medical device manufacturers