U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Pure Nootropics, LLC - 565425 - 06/04/2019
  1. Warning Letters

CLOSEOUT LETTER

Pure Nootropics, LLC MARCS-CMS 565425 —

Product:
Dietary Supplements

Recipient:
Recipient Name
Christopher Dziak
Pure Nootropics, LLC

10532 Figaro Dr Nw
Albuquerque, NM 87114-3890
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740
United States


Dear Mr. Dziak:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 565425, issued February 5, 2019. Based on our evaluation, it appears you have addressed the violations contained in the 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/
Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition