Sejong Medical said it has been suspended from manufacturing its disposable guide needles for three months by the Ministry of Food and Drug Safety after failing to obtain authorization after a change in the device's approval status. 

The administrative action will be enforced from Thursday to Dec. 27, and the suspension will amount to 4 billion won ($2.9 million), or 25.04 percent of the company's sales in 2022.

"The administrative penalty suspends manufacturing activities for the duration of the penalty, while sales and distribution activities are maintained," the company said. "As products manufactured or shipped before the date of suspension can be distributed and sold, we expect that the current inventory will be sufficient to respond as we have sufficient inventory of the affected items."

The company will do its best to prevent future recurrence by complying with relevant laws and regulations, it added.