Recipient NameTeresa Malanda, R.Ph.
- Malanda, Inc. dba Mandell's Clinical Pharmacy
7 Cedar Grove Lane
Somerset, NJ 08873-1331
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
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.
Acting Program Division Director/District Director
Office of Pharmaceutical Quality Operations