The Skin Atelier, Inc. d.b.a. Skinprint

CLOSEOUT LETTER The Skin Atelier, Inc. d.b.a. Skinprint MARCS-CMS 582512 — October 29, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3005976760 Product: Drugs Recipient: Recipient Name Mr. Robert P. Manzo Recipient Title President/CEO The Skin Atelier, Inc. d.b.a. Skinprint 1997 Route 17 M, Suite 10 Goshen , NY 10924 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States Secondary Issuing Offices United States Dear Mr. Manzo: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582512 dated October 1, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to CGMP violations. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Emily Wu Compliance Officer Division of Drug Quality II Content current as of: 11/05/2024 Regulated Product(s) Drugs