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Dongkook products denied entry into US after refusing FDA inspection
  • By Lee Han-soo
  • Published 2018.08.29 11:58
  • Updated 2018.08.29 11:58
  • comments 0

The U.S. Food and Drug Administration (FDA) added 10 Dongkook Pharmaceutical products on its import alert list in August for failing to allow inspection on its facilities.

Companies on the import alert list cannot export their products to the U.S. market, and the FDA detains the products that are already in the U.S. without physical examination until the firms allow inspection on its plants.

However, Dongkook Pharmaceutical argued that they had never refused an FDA inspection on its plants and the FDA’s announcement seems to be due to a communication error between the company and the FDA.

“We are currently selling over-the-counter (OTC) cosmetic products through an online platform in the U.S.,” a company spokesperson said to Korea Biomedical Review over the phone. “The FDA notified our company of its intention to conduct an inspection, and we sent a reply asking how to apply for the procedure.”

However, the FDA listed the company’s products on the import alert list while waiting for a reply, he added.

The company stressed that they have no reason to refuse the FDA’s request as they want to export its products.

“We plan to get off the list shortly as we are scheduling an FDA inspection on our facilities,” the official said. “The company expects to pass the inspection without any trouble as the FDA’s check-up for cosmetics products is not as demanding as drugs.”

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>

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