FDA 483 - PETNET Solutions, Inc. - April 24, 2023

PETNET Solutions, Inc. in Hayward, CA, a PET Drug Manufacturer, was inspected from April 19-24, 2023. The inspection revealed two significant issues: a failure to establish and follow written quality assurance procedures, particularly regarding operator training and trend analysis for environmental monitoring excursions, and inadequate cleaning and cleanliness verification of production equipment. These observations indicate deficiencies in the firm's quality control and aseptic processing practices.