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

During an inspection from December 2-13, 2019, the FDA issued a Form 483 to Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy, a producer of sterile drugs. The inspection revealed critical deficiencies in the facility's adherence to Good Manufacturing Practices. Significant issues included a failure to adequately evaluate and take action on actionable microbial contamination found in ISO 5 aseptic processing areas and adjacent ISO 7 cleanrooms. Mold and various bacteria were identified, yet the impact on numerous sterile drug products, such as Azacitidine and Vancomycin, was not assessed.

The facility's design and operation contributed to poor environmental control, with uncontrolled air balance leading to the influx of lower-quality air into higher-classified areas, and pressure differentials consistently outside specified ranges. Critical HEPA filters were not properly sealed or leak tested, and shared air handling units compromised air quality. Furthermore, personnel flow was inadequate, and non-sterile disinfectants were used in aseptic areas. Gowning procedures were also found to be improper, with gowns being reused after contact with bare hands.

To address these findings, the company must implement comprehensive corrective actions. This includes thoroughly investigating the identified contamination, assessing product impact, rectifying facility design flaws to ensure proper air quality and pressure control, establishing robust environmental monitoring, ensuring HEPA filter integrity, and revising and enforcing strict aseptic processing, gowning, and cleaning protocols with sterile materials.