FDA 483 - PETNET Solutions, Inc. - September 16, 2019

During an inspection, PETNET Solutions, Inc. in Hayward, CA, was cited for significant deficiencies in laboratory test records and computer system controls related to the manufacturing of Axumin (fluciclovine F 18). The firm's system for determining chemical purity lacked unique user access, had disabled data audit trails, and allowed operators to delete raw data. These issues indicate serious concerns regarding data integrity and compliance with good manufacturing practices.