Van Tibolli, LLC., dba GK Hair

CLOSEOUT LETTER Van Tibolli, LLC., dba GK Hair MARCS-CMS 451478 — May 26, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 20-HAFE4-WLCOL-08 Product: Dietary Supplements Recipient: Recipient Name Mr. Van Tibolli Recipient Title CEO Van Tibolli, LLC., dba GK Hair 1607 Ave. Ponce de Leon San Juan , PR 00909-1820 United States van.tibolli@VTBeauty.com Issuing Office: Office of Human and Animal Food Operations Division IV East United States (787) 729-8500 Dear Mr. Tibolli: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA 15-31 dated September 2, 2015. It appears that you have addressed the violations contained in this Warning Letter. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If you have any questions, contact Pearl Lopina, Compliance Officer at 407-475-4730 or pearl.lopina@fda.hhs.gov . Kind regards, /S/ Edwin Ramos Director of Compliance Branch OHAFO Division IV East Content current as of: 05/26/2020 Regulated Product(s) Dietary Supplements