- Delivery Method:
- Via Email Delivery Confirmation
Recipient NameClayton McGhan, MHA
Recipient TitleInterim West Hawaii Regional CEO
- Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
79-1019 Kaukapila Street
Kealakekua, HI 96750
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV