US FDA inspects Samsung Biologics facilities in South Korea

IANS May 21, 2025 372 views

The US Food and Drug Administration is currently conducting a significant site inspection at Samsung Biologics' facilities in Songdo, South Korea. This rare regulatory visit involves reviewing operational and safety protocols at the company's third and fourth plants. Samsung Biologics, a major global contract development and manufacturing organization, has instructed employees to maintain professional conduct during the inspection. The inspection aligns with the FDA's broader initiative to expand international manufacturing facility oversight, potentially signaling increased global regulatory scrutiny.

"Employees must exercise discretion during the inspection period" - Samsung Biologics Official
Seoul, May 21: The US Food and Drug Administration (FDA) is currently conducting an on-site inspection of Samsung Biologics' production facilities in South Korea, industry sources said on Wednesday.

Key Points

1

FDA reviews Samsung Biologics' production safety protocols

2

Unannounced foreign facility inspections expanding globally

3

Company reports 26.3% net profit increase in 2024

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 organisation (CDMO).

FDA officials reportedly visited the company's third and fourth plants Monday to review operations and safety protocols, reports Yonhap news agency.

Site inspections by overseas regulators at South 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.

Meanwhile, Samsung Biologics, a biotech arm of South Korea's Samsung Group, reported a 26.3 percent on-year rise in its 2024 net profit at 1.08 trillion won ($753 million).

In a regulatory filing, the company said it posted 1.32 trillion won in operating profit last year, compared with 1.11 trillion won from the previous year. Annual revenue rose 23.1 percent to a record 4.54 trillion won.

Samsung Biologics said increased deals for biosimilar helped jack up its bottom line.

It secured deals valued at over 5 trillion won, with its accumulated contracts tallied at US$17.6 billion.

Reader Comments

P
Priya K.
Interesting to see FDA expanding inspections globally. India should take note since we're also part of their pilot program. Our pharma companies must maintain world-class standards to compete with giants like Samsung Biologics. 🇮🇳
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Rahul S.
Samsung's growth in biotech is impressive! 26% profit increase is no joke. Indian companies like Biocon should learn from their contract manufacturing strategies. We have the talent but need better execution.
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Anjali M.
The FDA's unannounced inspection policy seems fair - quality shouldn't be compromised whether it's US, India or Korea. But hope they maintain consistency in standards across all countries. Sometimes developing nations face stricter scrutiny.
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Vikram P.
$17.6 billion in contracts?! 😲 South Korea is really leading in biotech while India is still playing catch-up in this sector. Our government should provide more incentives for biotech startups.
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Sanjay T.
While FDA inspections are important, I hope they don't become another tool for trade protectionism. Many Indian pharma companies have faced unnecessary hurdles despite maintaining good standards. Level playing field is crucial.
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Neha R.
The mandatory PPE and professional conduct instructions show how seriously Samsung takes these inspections. Indian companies could benefit from such discipline - sometimes we're too casual about protocols.

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Tags:
Samsung Biologics FDA Inspection Biotech Manufacturing South Korea Pharmaceuticals Regulatory Oversight