U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Xcel Sports Nutrition, LLC - 491533 - 11/26/2019
  1. Warning Letters

CLOSEOUT LETTER

Xcel Sports Nutrition, LLC MARCS-CMS 491533 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Donald Clement
Xcel Sports Nutrition, LLC

7408 82nd Street
Lubbock, TX 79424
United States

Issuing Office:
Division of Enforcement

United States

Dear Mr. Donald Clement:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #491533, issued March 7, 2016. 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 Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Back to Top