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CLOSEOUT LETTER

Liberty Drug & Surgical MARCS-CMS 485027 —

Delivery Method:
UPS Next Day Air
Recipient:
Recipient Name
Alan Brown
Recipient Title
President
Liberty Drug & Surgical
Liberty Drug & Surgical

195 Main Street
Chatham, NJ 07928
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

Dear Mr. Brown:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-NWJ-05 dated March 14, 2016. We acknowledge that your firm no longer produces sterile drug products and in the absence of a valid patient-specific prescription or medication order, shall not prepare compounded non-sterile preparations for human use except to the extent permitted by Federal law. 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/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations
Division I

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