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  5. Tris Pharma Inc. - 534537 - 12/27/2021
  1. Warning Letters

CLOSEOUT LETTER

Tris Pharma Inc. MARCS-CMS 534537 —

Delivery Method:
Via Email Delivery Confirmation
Product:
Drugs
Recipient:
Recipient Name
Mr. Ketan Mehta
Recipient Title
President and CEO
Tris Pharma Inc.

2033 US Highway 130
Suie D
Monmouth Junction, NJ 08852
United States

Issuing Office:
New Jersey District Office

United States

Dear Mr. Mehta:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS # 534537) dated March 26, 2018. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

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.

Respectfully,
/S/
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District

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