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Saffron USA LLC MARCS-CMS 629821 —

Delivery Method:
VIA Electronic Mail
Reference #:
Dietary Supplements

Recipient Name
Ms. Farangis Sedaghat
Recipient Title
Saffron USA LLC

504 Spring Island Way
Orlando, FL 32828
United States

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

United States

Dear Ms. Sedaghat:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 22-HAFE4-WL-07 dated September 23, 2022. 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.

Kind regards,
Pearl Lopina
Director of Compliance Branch
OHAFO, East Division IV

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