FDA 483 - Johnson Memorial Cancer Center - October 19, 2018

The FDA Form 483 details observations from an inspection of a facility producing chemotherapeutic and other sterile prescription drug products for injection.

Multiple violations related to environmental control and aseptic processing were noted. The firm failed to adequately evaluate, investigate, or take remedial action for actionable microbial contamination, including fungi known to produce mycotoxins and highly pathogenic microorganisms, found in both ISO 5 aseptic processing areas and adjacent ISO 7 areas. Similar mold recoveries in ISO 7 areas were also noted in a 2014 inspection.

Facility design allowed poor quality air into higher classified areas. The firm failed to maintain proper room classification and environmental control, with the air handling unit (AHU) offline for extended periods in May and June 2018, leading to elevated temperatures, humidity, and loss of differential pressures. Production continued during some AHU offline periods, including chemotherapeutic drugs, despite inadequate HEPA filtered airflow.

Cleaning and disinfection practices were deficient: non-sterile wipes were routinely used in ISO 5 areas, sterile sporicidal disinfectant and sterile wipes were not consistently applied to all interior surfaces of ISO 5 hoods, and contact time for sporicidal disinfectant differed from manufacturer recommendations. Risk assessments were not performed for the use of non-sterile wipes or for personnel cleaning activities where gloved hands and torsos contacted interior hood surfaces.

Poor aseptic techniques were observed, including elliptical cleaning motions, rapid personnel movement near open sterile units, and operators not sanitizing hands