Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy

Warning LetterClosed

Emily A. Krug Director of Pharmacy Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy 79-1019 Haukapila Street Kealakekua , HI 96750 United States emkrug@hhsc.orgFEI 3006684882Issued Feb 1, 2021Division of Pharmaceutical Quality Operations IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006684882.

Violations5

Issue DateFeb 1, 2021

Product TypeDrugs

StatusClosed

Closeout LetterJul 14, 2022

Letter Details

Firm: Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
Location: Emily A. Krug Director of Pharmacy Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy 79-1019 Haukapila Street Kealakekua , HI 96750 United States emkrug@hhsc.org
FEI Number: 3006684882
Country: United States
Issue Date: February 01, 2021
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Closed
Closeout Letter: July 14, 2022

Summary

Kona Community Hospital Pharmacy was cited for producing adulterated sterile drug products under insanitary conditions that violated federal manufacturing standards. FDA investigators found serious deficiencies in the pharmacy's sterile drug compounding practices during a December 2019 inspection, noting that products intended to be sterile were prepared, packed, or held in conditions where they may have become contaminated with filth or rendered injurious to health. The facility failed to comply with current good manufacturing practice (CGMP) requirements under Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act, putting patients at risk.

Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy FDA Warning Letter, February 1, 2021