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CLOSEOUT LETTER

Allay Pharmaceuticals, LLC MARCS-CMS 609023 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs

Recipient:
Recipient Name
Rosy Sultana
Recipient Title
CEO & President
Allay Pharmaceuticals, LLC

16600 NW 54th Ave
Unit 23
Hialeah, FL 33014-6109
United States

Issuing Office:
Division of Pharmaceutical Quality Operations II

United States


Ms. Sultana:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS No. 609023) dated January 27, 2021. 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/
Shawn Larson, PhD
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

 
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