Resource of K.Beauty’s Expertise


First in Korea to Lift Import Alert 66-40 for OTC GMP Violations


1)

Successfully Lifted Import Alert 66-40 for OTC GMP Violations—A First in Korea


We ensure that OTC products exported to the U.S. meet the labeling requirements under 21 CFR 201 and the OTC Label Guide, avoiding any misbranding issues. We also confirm compliance with the FDA’s Drug Facts requirements. 


In collaboration with a U.S.-based FDA consulting firm staffed by former FDA inspectors, we can certify that your OTC product labels have no misbranding issues and adhere to the FDA’s required Drug Facts format. 





2) 

Specialists in FDA CDER OTC Product Registration


We register OTC products intended for U.S. export in compliance with 21 CFR 207.

Resource of K.Beauty’s Expertise

First in Korea to Lift Import Alert 66-40 for OTC GMP Violations


1)

Successfully Lifted Import Alert 66-40 for OTC GMP Violations—A First in Korea 


We ensure that OTC products exported to the U.S. meet the labeling requirements under 21 CFR 201 and the OTC Label Guide, avoiding any misbranding issues. We also confirm compliance with the FDA’s Drug Facts requirements.


In collaboration with a U.S.-based FDA consulting firm staffed by former FDA inspectors, we can certify that your OTC product labels have no misbranding issues and adhere to the FDA’s required Drug Facts format.


2)

Specialists in FDA CDER OTC Product Registration

We register OTC products intended for U.S. export in compliance with 21 CFR 207.

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr