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CLOSEOUT LETTER

Gialive SA de CV MARCS-CMS 470118 —

Reference #:
Re:470118

Recipient:
Recipient Name
Edgar Arroyo Gonzalez
Recipient Title
General Director and Legal Representative
Gialive SA de CV
Gialive SA de CV

Carretera a Zacatecas km # 8
Col. TALAMANTES PONCE
20311 Aguascalientes, Ags.
Mexico

Issuing Office:

United States


Dear Mr. Edgar Arroyo Gonzalez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 470118, dated August 28, 2015. Based on our evaluation, it appears that you have addressed the violation(s) 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/
Carrie A. Lawlor
Branch Chief
Center for Food Safety and Applied Nutrition
Office of Compliance/ Division of Enforcement/Dietary
Supplement and Labeling Assessment Branch