The inspection, which commenced on Monday and is scheduled to run through May 27, is focused on evaluating the company’s manufacturing processes.
FDA officials visited Plants 3 and 4 on Tuesday, conducting what sources described as an "unusually detailed review." Such thorough site visits by foreign regulators are relatively rare, particularly in South Korea.
In anticipation of the inspection, Samsung Biologics has mandated that employees adhere to strict safety protocols, including the use of personal protective equipment.
The measure is reportedly intended to ensure compliance with both regulatory standards and internal safety procedures. Industry insiders noted that some members of the inspection team are Korean nationals.
A spokesperson for Samsung Biologics declined to provide specifics, citing client confidentiality.
"We cannot comment on inspection-related matters as they involve client information," the company said in a statement. The representative added that the current inspection is unrelated to a separate FDA initiative involving unannounced foreign facility visits.
The FDA has signaled plans to expand its oversight of overseas manufacturers of pharmaceuticals and food products.
According to the Korea Biotechnology Industry Organization, the effort builds on a pilot program launched under an executive order signed by President Donald Trump on May 5. The program, initially implemented in India and China, aims to align the scrutiny of foreign facilities with the standards applied to domestic manufacturers.
Under the order, the FDA was granted broader authority to increase foreign inspection fees and to enhance risk-based oversight mechanisms.
The agency was also tasked with ensuring that overseas facilities are inspected within 90 days of receiving orders and with making inspection frequency data publicly available by country and manufacturer.
Samsung Biologics, a key player in South Korea’s biopharmaceutical industry, has provided contract manufacturing services for a range of global pharmaceutical companies.
reporter
Kim Dong-young
davekim0807@ajupress.com
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