FDA 483 - Medical Center Pharmacy, Inc. - April 09, 2020

An FDA inspection of Medical Center Pharmacy, Inc. in Cleveland, TN, revealed significant deficiencies in aseptic processing and facility control. Observations included non-microbial and microbial contamination in classified areas, use of non-sterile cleaning agents, and inadequate testing for endotoxins and sterility. The firm also failed to properly segregate hazardous drug production and maintain calibrated equipment, indicating a severe lack of control over sterile drug manufacturing.