FDA 483 - PETNET Solutions, Inc - September 08, 2023

PETNET Solutions, Inc. in Phoenix, AZ, a PET drug product manufacturer, was cited for three observations during an FDA inspection. The firm's facilities were found inadequate for preventing contamination, leading to sterility test failures and consistent microbial recovery. Additionally, investigations into nonconforming PET drug batches were insufficient, and procedures for equipment cleaning and facility maintenance were not properly implemented, resulting in various deficiencies.