FDA 483 - ENDO USA, Inc. - October 18, 2021

An FDA inspection of PAR Sterile Products LLC in Rochester, MI, revealed significant deficiencies in their aseptic manufacturing processes and quality control systems. Observations included inadequate disinfectant efficacy studies, recurring HEPA filter failures without proper investigation, and a lack of accessible handwashing facilities. Additionally, the firm's environmental monitoring software was found to default to zero values, potentially masking actual contamination.