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Kona Community Hospital Pharmacy was cited for producing adulterated sterile drug products under insanitary conditions that violated federal manufacturing standards. FDA investigators found serious deficiencies in the pharmacy's sterile drug compounding practices during a December 2019 inspection, noting that products intended to be sterile were prepared, packed, or held in conditions where they may have become contaminated with filth or rendered injurious to health. The facility failed to comply with current good manufacturing practice (CGMP) requirements under Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act, putting patients at risk.