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  5. Revival Products, Inc. - 606640 - 08/05/2024
  1. Warning Letters

CLOSEOUT LETTER

Revival Products, Inc. MARCS-CMS 606640 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Suzanne S. Tabor
Recipient Title
President
Revival Products, Inc.

200 Peddycord Park Ct
Kernersville, NC 27284-9827
United States

Issuing Office:
Office of Human and Animal Food Operations – East Division 3

United States

Secondary Issuing Offices

United States

Dear Ms. Tabor:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS #606640 dated August 14, 2020. 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/
LCDR N’Jere English, Ph.D.
Compliance Officer
Office of Human and Animal Foods, East Division 3
Office of Regulatory Affairs
U.S. Food and Drug Administration

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