FDA Inspects Samsung Biologics Facilities: U.S. Regulators on the Ground in South Korea
(LEAD) Samsung Biologics-US FDA
SEOUL, May 21 (Yonhap) -- According to industry insiders on Wednesday, the U.S. Food and Drug Administration (FDA) is presently inspecting Samsung Biologics Co.’s manufacturing sites in South Korea in person.
As per the information provided, the FDA initiated an inspection at the premises of the company located in Songdo, which lies west of Seoul, with plans for it to extend until Tuesday. Samsung Biologics stands out as South Korea’s premier biotech firm and holds a significant position globally as a contract development and manufacturing organization (CDMO).
Reportedly, FDA officials went to the firm's third and fourth facilities on Monday to examine their processes and security measures.
An official from Samsung Biologics stated that the inspection is a component of the routine checks conducted by the FDA.
Samsung Biologics has instructed staff to be cautious throughout the inspection phase, with a requirement for compulsory usage of individual safety gear. The company has likewise highlighted the importance of maintaining professional behavior and interactions amongst personnel.
An official from Samsung Biologics refused to share detailed information but mentioned that the inspection is not connected to the FDA's current pilot initiative for surprise examinations of overseas facilities.
The Korea Biotechnology Industry Organization reports that the FDA has unveiled plans to increase surprise inspections of overseas manufacturing sites producing medical goods and food items.
This initiative stems from a pilot project that is presently underway in India and China, with the objective of extending the same degree of regulatory scrutiny to foreign plants as is applied to those operated within the United States.
odissy@yna.co.kr
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