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CLOSEOUT LETTER

N-Molecular Inc. d.b.a. SOFIE MARCS-CMS 553833 — Jul 02, 2019

N-Molecular Inc. d.b.a. SOFIE - 553833 - 07/02/2019

Delivery Method:
Certified Mail
Return Receipt Requested
Product:
Drugs

Recipient:
Recipient Name
Patrick W. Phelps
Recipient Title
President and CEO
N-Molecular Inc. d.b.a. SOFIE
SOPHIE Biosciences

6162 Bristol Parkway
Culver City, CA 90230
United States

Issuing Office:
Center for Drug Evaluation and Research

10 Waterview Blvd
3rd FL
Parsippany, NJ 07054
United States

(973) 331-4900

Dear Mr. Phelps:

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 # 553833) dated September 24, 2018. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Stephanie Durso, Compliance Branch Director
Office of Pharmaceutical Quality Operations, Division I