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

An FDA inspection of Joe Wise Pharmacy, Inc. DBA Wise Pharmacy in Littleton, CO, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing, hazardous drug handling, and environmental controls. Repeat observations from a previous inspection highlighted issues with the classification of aseptic areas and the presence of sinks in cleanrooms. The firm also failed to use pharmaceutical grade water and adequately monitor its aseptic processing environment.