Samsung Pharm hit with 3-month production suspension from Korean regulators

Samsung Pharm continues to get dinged by regulators who hit the drugmaker with a three-month suspension of all manufacturing operations after other sanctions were imposed earlier this year. (Fierce Pharma)

Samsung Pharm was hit with a three-month suspension of all manufacturing operations after Korea’s drug regulator found the company was using one production manager to oversee operations at two separate facilities, Korea Biomedical Review reports.

Under Korean law, drug manufacturers must have a production manager for each site or risk a three-month suspension as a first punishment. A second infraction would call for a six-month suspension, according to the publication.

Samsung Pharm had other sanctions levied against it earlier this year after inspectors found violations that included using additives without permission and the falsification of production records. The latest suspension started Monday and ends Feb. 14.

“In the future, Samsung Pharma will revisit the founding philosophy of ‘Protection of National Health’ and focus on its original duties as a pharmaceutical company,” the company said in a statement translated from Korean. “We will do our best to become a Samsung Pharma that can be trusted by shareholders, customers, medical staff and patients again by removing the complacency of the past.

The manufacturing halt will cost Samsung Pharm about $4.8 million, the company said in a financial filing.

Samsung Pharm is not affiliated with Samsung Biologics or Samsung Group.