FDA 483 - ENDO USA, Inc. - April 14, 2023

Par Sterile Products LLC in Rochester, MI, was cited for significant failures in following procedures designed to prevent microbial contamination of sterile drug products. The inspection revealed incomplete documentation of interventions, inadequate cleaning and disinfection practices, and multiple instances of operators not adhering to aseptic techniques during equipment setup and filling operations for Ephedrine Sulfate Injection. These deficiencies indicate a serious lack of control over aseptic processing, potentially compromising product sterility.