FDA 483 - Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy - December 13, 2019

An FDA inspection of Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy in Kealakekua, HI, revealed critical deficiencies in their sterile drug production. The firm failed to evaluate and address microbial contamination in ISO 5 aseptic processing areas and adjacent zones, indicating a severe lack of environmental control. Significant issues were also noted in facility design, including poor air balance, inadequate personnel/material flow, unsealed HEPA filters, and the use of non-sterile cleaning agents, all of which compromise the sterility of drug products.