Eco Lips, Inc.

CLOSEOUT LETTER Eco Lips, Inc. MARCS-CMS 631629 — August 22, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Air Product: Drugs Recipient: Recipient Name Robert P. Shriver Recipient Title Chief Operating Officer Eco Lips, Inc. 6000 Huntington Ct NT Cedar Rapids , IA 52402 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Shriver: The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter #631629 dated September 20, 2022. 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 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/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 08/30/2024 Regulated Product(s) Drugs