US FDA conducts inspection at Samsung Biologics facilities in S. Korea: Report

Seoul, May 21 (IANS) 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 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, Yonhap news agency reported.

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.

A Samsung Biologics official said the visit is part of the FDA's regular inspection.

Samsung Biologics has advised employees to exercise discretion during the inspection period, including mandatory use of personal protective equipment. It also emphasised 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 Organisation, 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 US manufacturers.

Meanwhile, in a survey carried out by the Korea Biotechnology Industry Organisation, more than seven out of 10 South Korean biotech companies are facing financial difficulties, Yonhap reported.

According to the survey, nearly four in 10 biotech companies in the country have considered selling their business.

About 74 per cent of chief executive officers (CEOs) and executives of 136 local biotech companies reported unstable funding conditions.

In addition, 76 per cent said their research and development (R&D) schedules have been disrupted due to funding challenges.

Based on the survey, the bio-organisation proposed 10 policy recommendations to the government aimed at strengthening the country's biotech ecosystem.

These include fostering startups, expanding research and development support, encouraging investment, creating a large-scale commercialisation fund, and easing financial regulations.

--IANS

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