Seoul, May 21 The US Food and Drug Administration (FDA) is currently conducting an on-site inspection of Samsung Biologics' production facilities in South Korea, industry sources said on Wednesday.
According to the sources, the FDA launched the inspection at the company's facilities in Songdo, west of Seoul, and is scheduled to continue through Tuesday. Samsung Biologics is South Korea's largest bio company and a major global contract development and manufacturing organisation (CDMO).
FDA officials reportedly visited the company's third and fourth plants Monday to review operations and safety protocols, reports Yonhap news agency.
Site inspections by overseas regulators at South Korean biomanufacturing plants are considered rare and are being closely watched by the industry.
Samsung Biologics has advised employees to exercise discretion during the inspection period, including mandatory use of personal protective equipment. It also emphasized professional conduct and communication among employees.
A Samsung Biologics official declined to provide specifics but stated that the inspection is unrelated to the FDA's ongoing pilot program for unannounced foreign facility inspections.
According to the Korea Biotechnology Industry Organization, the FDA has announced a plan to expand unannounced inspections of foreign manufacturing facilities that produce medical products and food.
The initiative is based on a pilot program currently being tested in India and China and aims to subject overseas facilities to the same level of regulatory oversight as U.S. manufacturers.
Meanwhile, Samsung Biologics, a biotech arm of South Korea's Samsung Group, reported a 26.3 percent on-year rise in its 2024 net profit at 1.08 trillion won ($753 million).
In a regulatory filing, the company said it posted 1.32 trillion won in operating profit last year, compared with 1.11 trillion won from the previous year. Annual revenue rose 23.1 percent to a record 4.54 trillion won.
Samsung Biologics said increased deals for biosimilar helped jack up its bottom line.
It secured deals valued at over 5 trillion won, with its accumulated contracts tallied at US$17.6 billion.
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