Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy

CLOSEOUT LETTER Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy MARCS-CMS 611130 — June 27, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Clayton McGhan, MHA Recipient Title Interim West Hawaii Regional CEO Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy 79-1019 Kaukapila Street Kealakekua , HI 96750 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Mr. McGhan: 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 #611130 dated February 23, 2021. 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. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 07/14/2022 Regulated Product(s) Drugs