South Korea's Sunjin Beauty Science has successfully passed a second United States Food and Drug Administration (FDA) inspection.
The company’s core products, UV filter materials, are classified as functional cosmetic ingredients for OTC drug use in the US are essentially recognized as major Active Pharmaceutical Ingredients (APIs).
The FDA conducts thorough on-site inspections of manufacturing facilities and quality systems—not only within the US, but also at overseas manufacturers.
In 2019, Sunjin passed its first FDA inspection, supported by proprietary plant design and robust quality systems.
Sunjin recently received from the FDA a Establishment Inspection Report reaffirming its capabilities under even stricter standards for the second inspection.
All of Sunjin Beauty Science’s inorganic UV filters are manufactured on a top-down closed production line optimized for APIs.
This system requires significant capital investment and mandates that more than 30% of the total production workforce be dedicated to quality-related roles such as QA and QC, resulting in higher manufacturing costs
"We’re honoured to announce that Sunjin Beauty Science has officially passed its second US FDA inspection — becoming the only company in Korea to do so twice in a row," said a Sunjin spokeswoman.
“This successful inspection once again officially confirms that our inorganic UV filters are produced in top-tier manufacturing facilities that meet the FDA’s Good Manufacturing Practice (GMP) requirements,” she added.
"This achievement is more than regulatory compliance — it is a powerful validation of our top-tier quality systems, pharmaceutical-grade manufacturing, and the relentless commitment of our team."
In a related development, Sunjin Beauty Science has unveiled its expanded Sunjin Clinical Research Centre (SCRC) in Seoul, Korea.
Following months of investment and innovation, SCRC now operates with: a five-times larger space, SCRC-exclusive technologies & AI-powered Raman spectroscopy, deepened collaboration with top-tier medical professionals; and full-spectrum efficacy and safety testing — all in-house.
The centre can measure many different types of skin analysis, including skin density, hydration, keratin, wrinkles, lifting, tone, texture, barrier, pigmentation and others.
“With enhanced capabilities, broader service reach, and an elite team of clinical experts, SCRC is not just a testing facility — it’s a strategic partner in our customers’ product development journey,” said the spokeswoman.
“From advanced UV testing to SCI-level imaging analytics, SCRC delivers industry-defining precision and reliability,” she added.
“We remain committed to leading with science and raising the global standard of clinical evaluation.”
