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U.S. FDA conducting inspection at Samsung Biologics facilities in Korea

Published: 21 May. 2025, 10:20

Samsung Biologics' logo is shown at the firm's offices in Incheon. [YONHAP]

The U.S. Food and Drug Administration (FDA) is currently conducting an on-site inspection of Samsung Biologics's production facilities in 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. Samsung Biologics is Korea's largest bio company and a major global contract development and manufacturing organization (CDMO).

FDA officials reportedly visited the company's third and fourth plants Monday to review operations and safety protocols.

Site inspections by overseas regulators at 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.

Yonhap