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  5. Queten Research Institute - 610021 - 06/28/2021
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CLOSEOUT LETTER

Queten Research Institute MARCS-CMS 610021 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Jill Seropian
Recipient Title
VP
Queten Research Institute

10 Bloomfield Ave.
Pine Brook, NJ 07058
United States

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

United States

Dear Ms. Seropian:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued to Queten Research Institute on November 5, 2020. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in the 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/
Andrew Ciaccia
Compliance Officer
Human and Animal Food East, Division II

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