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FDA Warning Letter Explorer
FDA warning letter · Drugs

Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy

Issued · Posted by FDA

FDA published a close-out letter on Jul 14, 2022. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to remediate the repeated recovery of microbial contamination from the ISO 7 cleanrooms, ISO 5 biological safety cabinet (BSC), and ISO 5 laminar air flow (LAF) hood where drug products intended to be sterile were prepared. Furthermore, you failed to evaluate whether the identified microbial contamination had any impact on aseptically processed drug products that were prepared in your cleanrooms.

Passage 2

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 BSC. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

Passage 3

You failed to evaluate whether the recovery of spore-forming organisms indicated a need for more frequent application of a sporicidal agent as part of your routine disinfection program.