8h ago
Nubratori, Inc. dba Nubratori Rx - 700513 - 07/27/2026
Nubratori, Inc. dba Nubratori Rx - 700513 - 07/27/2026
Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT Product: Drugs Recipient: Recipient Name Robert P. Nickell Recipient Title Chief Executive Officer Nubratori, Inc. dba Nubratori Rx 381 Van Ness Avenue, Suite 1507 Torrance , CA 90501-7220 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Nickell: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our warning letter #700513, issued on January 22, 2025 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 ensure 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/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research cc: Gulshakar Khwaja, RPH, MS, PharmD Director of Regulatory Affairs
Summary
Compounding Pharmacy/Adulterated Drug Products