SaveWay Compounding Pharmacy, Inc.

CLOSEOUT LETTER SaveWay Compounding Pharmacy, Inc. March 28, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: SaveWay Compounding 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 March 28, 2018 Brenda L. Poland Vice President SaveWay Compounding Pharmacy, Inc. 31 Albe Drive, Suite 1 Newark, DE 19702-1360 Dear Ms. Poland: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #17-PHI-01) dated October 4, 2016. 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/ Yvette Johnson, Compliance Officer Office of Pharmaceutical Quality Operations, Division I Philadelphia District Office Content current as of: 03/29/2018