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

On February 1, 2021, the FDA issued a Warning Letter to Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy following an inspection from December 2-13, 2019. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under FDCA Section 501(a)(2)(A).

Key violations include: 1. Failure to remediate repeated microbial contamination in ISO 7 cleanrooms, ISO 5 biological safety cabinet (BSC), and ISO 5 laminar air flow (LAF) hood, and failure to evaluate its impact on aseptically processed drugs. 2. Deficient facility design, including issues with cleanroom air filtration (unclamped, failed leak test HEPA filter), ceiling air returns, simultaneous opening of doors between classified and unclassified areas, inability to maintain differential pressure, and dust accumulation on air supply vents. 3. Failure to perform adequate smoke studies under dynamic conditions for the ISO 5 BSC. 4. Use of a non-sterile disinfectant in the ISO 5 aseptic processing area.

The FDA reviewed the firm's January 3, 2020, response but found it lacked sufficient information or supporting documentation for proposed corrective actions, such as finalized design changes, evidence of purchased equipment, proof of sterile cleaning agent use, additional environmental monitoring data, and evaluation of sporicidal agent frequency. The FDA strongly