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.
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