Shadow Holdings dba Bocchi Laboratories

CLOSEOUT LETTER Shadow Holdings dba Bocchi Laboratories MARCS-CMS 561273 — January 10, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Cosmetics Recipient: Recipient Name Joseph C. Pender Recipient Title CEO/President Shadow Holdings dba Bocchi Laboratories 26421 Ruether Ave Santa Clarita , CA 91350-2621 United States Issuing Office: Division of Human and Animal Food Operations West V United States Dear Mr. Pender: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #561273 dated February 6, 2019. Based on our evaluation, 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 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 Agency 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/ Sergio Chavez, Compliance Branch Director Office of Human and Animal Food Operations West Division 5 Content current as of: 01/15/2020 Regulated Product(s) Cosmetics