Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy

CLOSEOUT LETTER Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy MARCS-CMS 557802 — January 05, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Adam Israel Recipient Title CEO Gipsco Investment Corporation dba Lee Silsby Compounding Pharmacy 23865 Mercantile Rd Beachwood , OH 44122-5907 United States adam@leesilsby.com Issuing Office: Detroit District Office United States Dear Mr. Israel: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case #557802), dated July 10, 2018. 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 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/ Nicholas F. Lyons Director, Compliance Branch Division of Pharmaceutical Quality Operations III Content current as of: 01/13/2023 Regulated Product(s) Drugs