FDA 483 - Mayo Clinic Pharmacy - August 15, 2018

An FDA inspection of Mayo Clinic Pharmacy in Rochester, MN, a producer of sterile and non-sterile products, revealed significant deficiencies in aseptic processing and contamination control. Observations included inadequate evaluation of microbial contamination in ISO 5 areas, presence of non-microbial contamination, use of non-sterile disinfectants, and insufficient disinfectant contact times. Additionally, the firm failed to perform endotoxin testing for certain multi-dose sterile products.