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  5. Lavian Ltd - 495981 - 04/30/2019
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CLOSEOUT LETTER

Lavian Ltd MARCS-CMS 495981 — Apr 30, 2019

Lavian Ltd - 495981 - 04/30/2019

Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Food & Beverages

Recipient:
Recipient Name
Amos Lavian
Recipient Title
President
Lavian Ltd

960 South Broadway
Suite 122
Hicksville, NY 11801
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

158-15 Liberty Avenue
Jamaica, NY 11433
United States


Dear Mr. Lavian:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2016-39, issued on July 22, 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 a subsequent inspection or through other means.

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