FDA WARNING_LETTER - Ami Cosmetics Co., Ltd. - July 11, 2018

The FDA issued a Warning Letter to Ami Cosmetics Co., Ltd. on June 12, 2018, regarding inaccurate listing information for their drug product, PureHeals Centella 70 Toning Swab, NDC 59535-0268. This follows previous letters from July 17, 2017, and April 9, 2018, which detailed these deficiencies.

The violations stem from the failure to comply with Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 207.49, which outline requirements for drug product registration and listing. Specifically, the electronic listing file for PureHeals Centella 70 Toning Swab does not match the provided labeling. The proprietary name on the carton label image is "Jeju: En Black Bean Ferment Emulsion," not "PureHeals Centella 70 Toning Swab." Furthermore, the active ingredient "Adenosine" identified in the labeling's "Drug Facts" section is not included in the listing file, which only specifies "Glycerin" as an active ingredient.

These failures constitute a violation of Section 301(p) of the FD&C Act, misbranding the product under Section 502(o), and prohibiting its introduction into interstate commerce under Section 301(