FDA WARNING_LETTER - Cosmo Bio Co., Ltd. - January 18, 2022

On January 6, 2022, the FDA issued a Warning Letter to Cosmo Bio Co., Ltd. (FEI 3015297228) in Daejeon, South Korea, following a review of records submitted in response to an April 22, 2020, request. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug product, Georganic Propolis Acne Care Serum, adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. Failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to drug product release (21 CFR 211.165(a)). 2. Failure to establish and follow an adequate written stability testing program to determine storage conditions and expiration dates (21 CFR 211.166(a)). 3. Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment, specifically lacking cleaning validation for shared product-contact equipment (21 CFR 211.67(b)).

Furthermore, Georganic Propolis Acne Care Serum is deemed an unapproved new drug and misbranded. It is an unapproved new drug because its active ingredient, "propolis," is not