Is the US FDA Inspecting Samsung Biologics in South Korea?

Seoul, May 21 (NationPress) The U.S. Food and Drug Administration (FDA) is presently carrying out an on-site evaluation of Samsung Biologics' production facilities located in South Korea, as reported by industry insiders on Wednesday.

Sources indicate that the FDA initiated this inspection at the company's facilities in Songdo, situated west of Seoul, with the process slated to extend through Tuesday, according to Yonhap news agency.

Samsung Biologics holds the title of South Korea's largest biotech firm and is a prominent global contract development and manufacturing organization (CDMO).

FDA representatives reportedly toured the company's third and fourth manufacturing plants on Monday to assess operational practices and safety measures.

A spokesperson for Samsung Biologics stated that this visit is part of the FDA's routine inspection regimen.

During the inspection period, Samsung Biologics has instructed its employees to maintain discretion, mandating the use of personal protective equipment. The company has also highlighted the importance of professional behavior and communication among staff members.

While a Samsung Biologics representative chose not to disclose detailed information, it was confirmed that the inspection is not linked to the FDA's ongoing pilot program focused on unannounced inspections of foreign facilities.

The Korea Biotechnology Industry Organisation notes that the FDA intends to broaden its scope of unannounced inspections for foreign manufacturing sites producing medical goods and food.

This initiative is based on a pilot program currently being implemented in India and China and aims to provide overseas facilities with the same regulatory scrutiny as their U.S. counterparts.

In a related note, a survey conducted by the Korea Biotechnology Industry Organisation revealed that over 70% of South Korean biotech firms are encountering financial hardships, as reported by Yonhap.

The findings indicate that nearly 40% of biotech companies in the nation are contemplating selling their businesses.

Approximately 74% of CEOs and executives from 136 local biotech firms reported facing unstable funding conditions.

Moreover, 76% indicated that their research and development (R&D) timelines have been disrupted due to financial constraints.

Based on this survey, the bio-organization has proposed 10 policy recommendations to the government aimed at fortifying the country's biotech ecosystem.

These include supporting startups, enhancing R&D funding, promoting investment, establishing a large-scale commercialization fund, and relaxing financial regulations.