This photo, provided by Samsung Biologics Co., shows the company’s production plant in Songdo, west of Seoul. (Yonhap)
SEOUL, May 21 (Korea Bizwire) — The U.S. Food and Drug Administration (FDA) is currently conducting an on-site inspection of Samsung Biologics Co.’s 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. Samsung Biologics is South 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.
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 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)
