FDA 483 - Joe Wise Pharmacy, Inc. - June 21, 2019

During an inspection conducted from June 12-21, 2019, the Food and Drug Administration (FDA) issued a Form 483 to Joe Wise Pharmacy, Inc., operating as Wise Pharmacy, a producer of sterile and non-sterile drug products in Littleton, CO. The inspection revealed significant observations related to the firm's adherence to good manufacturing practices. Key issues included critical deficiencies in aseptic processing, such as the ISO 5 aseptic area being situated within a non-classified room lacking HEPA filtration and personnel performing non-sterile compounding in the same space. This observation, along with the presence of sinks in the aseptic processing area, were noted as repeat findings from a prior inspection. Further concerns involved inadequate containment and cleaning protocols for hazardous drugs, potentially leading to cross-contamination, and the use of non-pharmaceutical grade water in various human drug products. The FDA also observed a lack of dynamic certification for ISO 5 classified areas, specifically the absence of smoke studies to verify unidirectional airflow, and a failure to properly conduct environmental monitoring in aseptic processing areas, with samples incubated at uncontrolled temperatures. The FDA 483 serves as a notification of objectionable conditions observed during an inspection, requiring the company to evaluate these findings and provide a comprehensive response detailing its planned or implemented corrective actions to address each observation and ensure compliance.