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  5. Van Tibolli, LLC., dba GK Hair - 451478 - 05/26/2020
  1. Warning Letters


Van Tibolli, LLC., dba GK Hair MARCS-CMS 451478 —

Delivery Method:
VIA Electronic Mail
Reference #:
Dietary Supplements

Recipient Name
Mr. Van Tibolli
Recipient Title
Van Tibolli, LLC., dba GK Hair

1607 Ave. Ponce de Leon
San Juan, PR 00909-1820
United States

Issuing Office:
Office of Human and Animal Food Operations Division IV East

United States

(787) 729-8500

Dear Mr. Tibolli:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA 15-31 dated September 2, 2015. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If you have any questions, contact Pearl Lopina, Compliance Officer at 407-475-4730 or pearl.lopina@fda.hhs.gov.

Kind regards,
Edwin Ramos
Director of Compliance Branch
OHAFO Division IV East

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