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  5. Malanda, Inc. dba Mandell's Clinical Pharmacy - 608320 - 11/09/2022
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CLOSEOUT LETTER

Malanda, Inc. dba Mandell's Clinical Pharmacy MARCS-CMS 608320 —

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

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