Calvin Scott & Company, Inc.

CLOSEOUT LETTER Calvin Scott & Company, Inc. MARCS-CMS 606987 — August 04, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Jan-Erik Palm Recipient Title President Calvin Scott & Company, Inc. 209 Eubank Blvd NE Albuquerque , NM 87123 United States jepalm@calvinscottinc.com Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Mr. Palm: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #606987) dated August 25, 2020. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 08/10/2023 Regulated Product(s) Drugs