SaveWay Compounding Pharmacy, Inc. - Close Out Letter 3/28/18
- SaveWay Compounding Pharmacy, Inc.
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.
Yvette Johnson, Compliance Officer
Office of Pharmaceutical Quality Operations, Division I
Philadelphia District Office