SUNJIN NEWSLETTER
Sunjin Beauty Science’s Quality Strategy to Meet
Strengthened Random FDA Inspections
By Lee, James
June 2025, NO.23
Hi, how are you?
In 2019, Sunjin Beauty Science became the first Korean cosmetic ingredient manufacturer to undergo an on-site inspection by the U.S. Food and Drug Administration (FDA), successfully passing with a No Action Indicated (NAI) rating.
This result signifies that our manufacturing operations and quality management systems are in full compliance with FDA regulations, requiring no corrective actions. It is a strong testament to the international quality and safety standards that Sunjin Beauty Science upholds in all our products.
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a policy to strengthen unannounced inspections of overseas manufacturing facilities.
This initiative aims to apply the same level of regulatory oversight to foreign manufacturing sites as those within the United States, reinforcing the safety and quality of food, pharmaceuticals, medical devices, and cosmetics supplied to American consumers.
Previously, inspections of overseas manufacturing sites were typically conducted with prior notice. However, this approach has drawn criticism for potentially failing to reflect the facility’s actual operating conditions. To address these concerns, the FDA has announced plans to actively implement unannounced inspections moving forward.
As part of this initiative:
– Inspectors will no longer accept any assistance from the facility regarding lodging or transportation.
– The FDA has clarified its authority to take strong regulatory actions in cases where inspections are delayed, refused, or limited by the manufacturer.
The FDA conducts approximately 12,000 domestic and 3,000 international inspections annually. Despite prior notifications, overseas facilities have been found to have more than double the rate of significant deficiencies compared to domestic sites. This highlights the need for enhanced transparency and effectiveness in the inspection process, driving recent policy changes.
In response to the FDA’s recent policy changes, Sunjin Beauty Science is proactively strengthening its quality management by:
– Enhancing internal quality training programs
– Advancing record-keeping and documentation systems
– Conducting regular audits of GMP-compliant manufacturing environments and quality systems
Through these measures, we are committed to maintaining rigorous compliance and ensuring the highest standards of product safety and quality.
Moving forward, Sunjin Beauty Science will continue to uphold and enhance our quality systems that lead international standards, ensuring all our customers receive consistently reliable and trustworthy products.
Should you have any inquiries, please feel free to contact us at the information below.
Areum Jeong / Regional Sales Manager
E-mail : sales1@sunjinbs.com
