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  5. Premier Nutra Pharma Inc. - 640210 - 10/11/2023
  1. Warning Letters

CLOSEOUT LETTER

Premier Nutra Pharma Inc. MARCS-CMS 640210 —

Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Israel Kravzov
Recipient Title
Co-Chief Executive Officer
Premier Nutra Pharma Inc.

5800 Newton Drive
Carlsbad, CA 92008
United States

ikravzov@premiernutrapharma.com
Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Dear Mr. Kravzov:

The U.S. Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case # 640210; dated December 9, 2022]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. 


Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV


cc: Hector Gudino
Co-Chief Executive Officer
Premier Nutra Pharma Inc.
hector@premiernutrapharma.com

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