The Ministry of Food and Drug Safety has suspended the import of GSK’s disposable biopsy punch for three months. The suspension began last Friday and will continue through Oct. 7.

The disposable 6-mm biopsy punch, primarily used in dermatology clinics for therapeutic, diagnostic, and research purposes, is a Grade 2 medical device.

Under the Korean medical device laws, a company needs a good manufacturing practice (GMP) certification for factories that manufacture Grade 2 medical devices to market them in Korea. The certification lasts for three years before renewal.

However, GSK Korea had sold the product in Korea even though the product’s overseas manufacturer failed to renew its GMP accreditation from the Korean regulators last year, resulting in the recent three-month import ban, according to the ministry.

At the time, GSK released a statement explaining that the company had imported the device through SFM medical devices GmbH, a German manufacturing company. “However, SFM failed to renew its GMP accreditation last year, and the certification expired on July 23, 2021,” the company said. “Despite failing to renew its GMP certification, GSK Korea had stored the product in a warehouse in Korea after receiving quality control (QA) shipment approval from Korean authorities.”

GSK noted that while the company had decided not to proceed with product release until SFM renewed its GMP accreditation, it failed to take adequate measures, releasing 320 boxes of its product in October and November without authorization.

The company began an immediate recall process but failed to retrieve 14 boxes as the products had already been used. GSK will conduct a medical evaluation of product quality and patient safety and report the results to the ministry.

GSK Korea was unavailable for immediate comments regarding the latest import ban.