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. Niche Pharmaceuticals, Inc - 553911 - 08/13/2019
  1. Warning Letters

CLOSEOUT LETTER

Niche Pharmaceuticals, Inc MARCS-CMS 553911 —

Delivery Method:
UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Stephen F. Brandon, Sr.
Recipient Title
Owner & CEO
Niche Pharmaceuticals, Inc

580 Commerce Street
Ste. 100
Southlake, TX 76092-9156
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

4040 North Central Expressway
Suite 300
Dallas, TX 75204-3138
United States

Dear Mr. Brandon:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 553911) on June 19, 2018. Based on our evaluation, it appears that you have 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/
Dana M. Lewis
Compliance Officer
Office of Human and Animal Food-West Div. 3

Back to Top