- Delivery Method:
- Via Email
Recipient NameHeeJoo Park, RPh
Recipient TitlePresident and CEO, COO, CFO
- Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
530 South 336th Street
Federal Way, WA 98003-6383
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
Irvine, CA 92612-2506
Dear Ms. Park:
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# 552431) dated April 4, 2018. 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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV