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  5. Biorica International Corp. - 659194 - 04/09/2024
  1. Warning Letters

CLOSEOUT LETTER

Biorica International Corp. MARCS-CMS 659194 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Jacqueline Baxas
Recipient Title
President
Biorica International Corp.

4310 Sheridan St., Suite 202
Hollywood, FL 33021
United States

info@biorica.biz
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Secondary Issuing Offices

United States

Dear Ms. Baxas:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #659194, issued August 4, 2023. 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

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