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. Performance Nutrition Formulators LLC dba VMI Sports - 543959 - 02/09/2023
  1. Warning Letters

CLOSEOUT LETTER

Performance Nutrition Formulators LLC dba VMI Sports MARCS-CMS 543959 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Thomas M. Reilly, Mr. Frank Fenimore Jr.
Recipient Title
President/Partner, CEO/ Partner
Performance Nutrition Formulators LLC dba VMI Sports

100 Tec Street Unit B
Hicksville, NY 11801
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Dear Mr. Reilly and Mr. Fenimore Jr.:

The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 543959, issued on May 18, 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/
Lillian Aveta
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1

Back to Top