News Letter

Hello,

Sunjin Beauty Science has successfully passed its second FDA inspection.
What does this mean?
Our core products, UV filter materials, are classified as functional cosmetic ingredients for OTC drug use in the United States and are essentially recognized as major Active Pharmaceutical Ingredients (APIs).
Because of this, the U.S. FDA conducts thorough on-site inspections of manufacturing facilities and quality systems—not only within the U.S., but also at overseas manufacturers.

In 2019, we achieved a major milestone by successfully passing our first FDA inspection, supported by our proprietary plant design and robust quality systems.
This past August, the second inspection was conducted under even stricter standards, and in early November, we officially received the final Establishment Inspection Report (ERI), reaffirming our capabilities once again.

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.

All of Sunjin Beauty Science’s inorganic UV filters are manufactured on a top-down closed production line optimized for APIs (Active Pharmaceutical Ingredients). 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. However, this level of investment enables large-scale production with extremely low variability, ultimately delivering consistently superior quality that our customers can trust.

Many companies receive numerous observations or even fail to pass during the FDA inspection process. This is because an FDA inspection goes far beyond checking regulatory compliance—it rigorously evaluates the overall quality management system and the transparency of the organization.
In this context, successfully passing our second FDA inspection clearly demonstrates that Sunjin Beauty Science’s manufacturing capabilities and quality management systems are truly among the best in the world.

Building on our innovative manufacturing infrastructure and continuous R&D efforts, Sunjin Beauty Science will continue to expand its portfolio of “Global First & Only” products. We remain committed to being the most trusted partner for our customers’ success and to setting new standards in the global raw material market.

For inquiries about this product, please contact us using the information below.

Areum Jeong / Regional Sales Manager

E-mail : sales1@sunjinbs.com