Malanda, Inc. dba Mandell's Clinical Pharmacy

CLOSEOUT LETTER Malanda, Inc. dba Mandell's Clinical Pharmacy MARCS-CMS 608320 — November 09, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Teresa Malanda, R.Ph. Recipient Title Pharmacist/Owner Malanda, Inc. dba Mandell's Clinical Pharmacy 7 Cedar Grove Lane Somerset , NJ 08873-1331 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States Dear Ms. Malanda: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL# 608320) dated June 9, 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 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/ Nerizza Guerin Acting Program Division Director/District Director Office of Pharmaceutical Quality Operations Division I Content current as of: 11/21/2022 Regulated Product(s) Drugs