FDA 483 - Mayo Clinic PET Radiochemistry Facility - April 12, 2019
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The FDA issued a Form 483 to Mayo Clinic PET Radiochemistry Facility in Jacksonville, FL, citing significant deficiencies in contamination control and equipment qualification. The inspection revealed inadequate facilities and a failure to properly evaluate disinfectants for aseptic areas, leading to microbial contamination. Additionally, the firm lacked proper documentation to ensure equipment, specifically a laminar flow hood, was suitable for maintaining sterile conditions.
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ID · 88225acb-31ab-4d16-9d9a-5aaef92155d7