FDA 483 - Petnet Solutions Inc - June 24, 2021

An FDA inspection of PETNET Solutions South Florida in Fort Lauderdale revealed significant deficiencies in their PET drug manufacturing processes. The firm failed to demonstrate process capability through adequate media fills and lacked thorough Quality Assurance oversight during site start-up. Issues included improper handling of components, insufficient corrective actions for deviations, and inadequate controls over equipment suitability, facility contamination prevention, laboratory documentation, and production computer timestamps.