Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
FDA issued a warning letter to Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy (Kona Community Hospital Pharmacy, Kealakekua, HI) following a December 2019 inspection that found serious insanitary conditions in sterile drug compounding operations, including repeated microbial contamination in cleanrooms, deficient facility design, inadequate smoke studies, and use of a non-sterile disinfectant in aseptic processing areas. These conditions caused the compounded sterile drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The pharmacy's corrective action responses were deemed insufficient due to lack of supporting documentation. FDA warned that failure to promptly correct violations may result in seizure and injunction, and required a written response within 15 working days.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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