Korean regulators shut down Samsung Pharma manufacturing after finding additives, false records

08 Nov 2021
endpts.com
South Korea’s health regulator has suspended Samsung Pharmaceutical’s manufacturing operations until mid-February after the agency learned that a production manager was tasked with responsibilities of two different plants. The revelation violated a law requiring each plant to be managed by one person. Monday’s halt comes just months after an inspection revealed a number of violations at one Samsung Pharma plant, including the use of additives without permission and false manufacturing records, the Korea Biomedical Review reported . Six drugs, including five of Samsung Pharma’s, have been suspended from being manufactured. Geramin, Moarex, Combicin, and an Aprogen Pharmaceutical drug Healthnamine have all been halted. The company is in no way affiliated with the South Korean electronics giant Samsung, or its subsidiary Samsung Biologics, a representative for the company said. In a statement on its website, Samsung Pharma attributed the error to negligence, and carelessness in checking in on the manager’s work, and insisted that it was not a problem with the quality of products shipped. “Nevertheless, (we are) deeply reflecting on the inconvenience caused by not thoroughly complying with the standards that we, as pharmaceutical manufacturers, should abide by,” the statement said. The three-month suspension is the first step in a series of potential punishments for companies who violate the law that prevents the double-dipping of employees. The next is a six-month manufacturing suspension, and the third strike will see the agency revoke a businesses license, Korea Biomedical Review reported. The suspension will start today and end on Feb. 14. Additional sanctions include the halt of manufacturing injections for five weeks and a four-month suspension of the five drugs under scrutiny. In a public statement, the company announced that the suspension would cost the company 5.7 billion won, or roughly $4.8 million. In June , a temporary suspension was ordered after violations surfaced, and the six drugs were forced to be recalled. Samsung Pharma illegally used additives arbitrarily and created false documents to cover up the violations. Regulators have also punished companies such as Vivozon and Binex for similar violations. The news brought down the company’s stock in the South Korean market when it first broke in June. But shares faltered very little after Monday’s news broke, still closing higher than the previous day. In the statement, Samsung Pharma said that it would revisit its founding philosophy and focus on its original duties as a pharmaceutical company. “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,” it said.
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