FDA 483 - Sparhawk Laboratories Inc - May 09, 2025

An FDA inspection of Sparhawk Laboratories Inc. in Lenexa, KS, revealed significant deficiencies in aseptic processing procedures, personnel practices, and environmental monitoring for sterile drug products. The inspection also identified issues with laboratory controls, including inaccurate documentation of microbial monitoring and inadequate qualification procedures for personnel. These findings indicate a serious lack of control over critical manufacturing and testing processes, potentially impacting product sterility and quality.