FDA EIR - PETNET Solutions, Inc. - January 31, 2020

PETNET Solutions Inc. in Culver City, CA, underwent a pre-approval and Good Manufacturing Practice (GMP) inspection by the FDA from January 27 to January 31, 2020. This inspection focused on their role as a Positron Emission Tomography (PET) drug manufacturer, specifically supporting an NDA and adherence to Compliance Program 7356.002P covering quality, facility, equipment, production, and laboratory controls. The inspection resulted in a nine-item Form FDA-483, detailing several objectionable conditions. Key violations included inadequate procedures for trending environmental monitoring and manufacturing process controls for a specific drug. The facility in room 4 lacked sufficient controls to prevent contamination. Issues were also identified with system suitability acceptance criteria for analytical equipment, qualification of a critical component vendor, and incoming acceptance and testing procedures for components and reference standards. Furthermore, the company failed to establish an approved procedure for analytical verification tests of compendial assays and adequate environmental controls. Finally, the inspection noted a failure to take appropriate action to prevent recurrence of nonconforming products or other quality problems. PETNET Solutions' management committed to submitting a written response to the FDA within fifteen business days addressing these observations.