Maple Rose Enterprises, Inc, dba Pencol Pharmacy

CLOSEOUT LETTER Maple Rose Enterprises, Inc, dba Pencol Pharmacy MARCS-CMS 520095 — March 10, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Tony E. Jones Recipient Title Owner Maple Rose Enterprises, Inc, dba Pencol Pharmacy 1325 S. Colorado Blvd Suite B-024 Denver , CO 80222 United States Issuing Office: Los Angeles District Office United States Dear Mr. Jones: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (Ref CMS 520095) dated August 2, 2017. 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/ Lance M. De Souza Acting Director, Pharmaceutical Quality Operations IV Content current as of: 03/14/2022 Regulated Product(s) Drugs