FDA 483 - Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - September 23, 2020

An FDA inspection of Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy in Seattle, WA, revealed significant deficiencies in both sterile and non-sterile drug production. Observations included inadequate disinfection of materials, poor facility design allowing air quality issues, visibly dirty aseptic processing areas, improper personnel gowning, and insufficient cleaning procedures for equipment used with hazardous drugs, raising concerns about product sterility and cross-contamination.