FDA 483 - Kreitchman PET Center - September 13, 2019

An FDA inspection of Kreitchman PET Center in New York, NY, a PET drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately investigate out-of-specification results and discrepancies, lacked proper written production and process control procedures, and maintained unsuitable laboratory analytical methods. Additionally, there were no established quality assurance procedures for data review and inadequate control over laboratory reagents and supplies, including expired materials.