PetNet Solutions Inc – FDA EIR, Apr 8, 2022

During an FDA pre-approval inspection of PETNET Solutions Inc.'s Elk Grove Village, IL facility from April 5-8, 2022, two significant observations were identified and discussed with management, though no formal inspectional observations (Form FDA 483) were issued. The inspection was conducted under Compliance Program 7356.002P, focusing on Positron Emission Tomography (PET) drug Current Good Manufacturing Practices (CGMP) and pre-approval requirements for the Axumin (Fluciclovine F-18 Injection) drug product. The primary issues involved deficiencies in manufacturing documentation and equipment traceability. Firstly, critical manufacturing steps, specifically the addition and type of filter used to transfer Axumin from an intermediate container to the final product vial, were not adequately documented in the batch production record. Secondly, media fill records lacked specific incubator equipment identification, preventing full traceability to the incubation conditions. PETNET Solutions Inc. management acknowledged these findings and committed to implementing corrective actions. A Corrective and Preventive Action (CAPA) plan was initiated by the firm to address the batch record documentation issue.