Vi-Jon, LLC

CLOSEOUT LETTER Vi-Jon, LLC MARCS-CMS 622087 — March 08, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Richard Koulouris Recipient Title Chairman and CEO Vi-Jon, LLC Consumer Product Partners, LLC 8800 Page Avenue St. Louis , MO 63114 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Koulouris: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 622087], dated March 31, 2022. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter. 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/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 03/15/2024 Regulated Product(s) Drugs