Leiter's Enterprises, Inc. dba Leiter's

CLOSEOUT LETTER Leiter's Enterprises, Inc. dba Leiter's MARCS-CMS 477540 — May 29, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Leiter's Enterprises, Inc. dba Leiter's United States Issuing Office: United States Division of Pharmaceutical Quality Operations IV 19701 Fairchild Road, Irvine, CA 92612 Telephone: (949) 608-2900 Fax: (949) 608-4417 May 29, 2018 Robin Smith Hoke, President and CEO Leiter’s Enterprises, Inc. dba Leiter’s 17 Great Oaks Blvd. San Jose, CA 95119-1359 Dear Ms. Hoke: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL# 477540), dated February 29, 2016. From June 7, 2017, to June 15, 2017, an FDA investigator conducted a reinspection of your facility, Leiter’s Enterprises, Inc. dba Leiter’s, located at 17 Great Oaks Blvd., San Jose, CA 95119-1359. 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/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 06/07/2018