Vivozon, Inc.

An FDA inspection found several issues including spore-related contamination in the manufacturing area at a site in the city of Chuncheon, South Korea. The inspection took place between Aug. 12 and Aug. 20 last year at the NO. 2 factory for Hugel, a maker of botulinum toxin(s), dermal fillers and other aesthetic products. The inspection itself found several major observations at the site in FDA documents that were disclosed on Tuesday. The Form 483 noted that clostridium botulinum spores, which can cause illness , were present in the company’s drug substance manufacturing areas. The FDA noted that the area could not stop spore contamination risk to other manufacturing areas. The FDA also found that the site’s decontamination efforts were not adequate as the disinfectants used were not able to decontaminate the spores. The Form 483 also noted that the spores were not a part of standard environmental monitoring at the site. In addition, the FDA found an impurity with a particular product batch and found that more than 12 logbooks went missing after several years. A working cell bank that is used to manufacture drugs was found to be mixed up with another working cell bank. A batch failure was also noted by the FDA with damaged vials and operators taking breaks being major causes. Hugel joins several manufacturers in Korea that have hit regulatory walls in the past year. Last year, Samsung Pharmaceutical’s manufacturing operations had to be suspended after South Korea’s health regulator found that a production manager was tasked with responsibilities for two different plants, which violated a law requiring each plant to be managed by one person. This led to six drugs being halted from being produced for several months. In April of this year, Vivozon had to halt drug production and was ordered to recall and discard 13 drugs after violating good manufacturing practice standards. Other companies such as Celltrion and Daewoong Pharmaceutical have also received observations from the FDA since 2017.

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.