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  5. Annemarie Gianni Skin Care LLC - 495979 - 02/12/2020
  1. Warning Letters

CLOSEOUT LETTER

Annemarie Gianni Skin Care LLC MARCS-CMS 495979 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Annmarie and Kevin Gianni
Recipient Title
Founders
Annemarie Gianni Skin Care LLC

2251 5th St
Berkeley, CA 94710-2216
United States

Issuing Office:
Office of Human and Animal Food Operations East - Division 1

United States

Dear Ms. Gianni and Mr. Gianni:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 495979 dated July 15, 2016. 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 subsequent inspection or through other means.

Sincerely,
/S/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East - Division 1

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