Walter's Pharmacy, Inc.

CLOSEOUT LETTER Walter's Pharmacy, Inc. MARCS-CMS 506596 — May 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Walter's Pharmacy, Inc. United States Issuing Office: United States Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 Wednesday, May 9, 2018 Mr. Howard Anthony, Owner Walter’s Pharmacy, Inc. 401 N 17th St Allentown, PA 18104-5034 Dear Mr. Anthony: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (17-PHI-03; CMS # 506596) issued on January 11, 2017. We acknowledge that your firm no longer produces sterile drug products. 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. If you decide to resume production of drug products intended to be sterile, FDA strongly recommends that you undertake a comprehensive assessment of your operations, including facility design, and that you notify FDA prior to resuming sterile production. 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 Division Director/OPQ Division 1 New Jersey District Office Content current as of: 05/17/2018