FDA 483 - ENDO USA, Inc. - April 15, 2019

PAR Sterile Products LLC in Rochester, MI, a sterile drug manufacturer, was cited for deficiencies in its batch production and control records. The inspection revealed a lack of complete documentation for significant manufacturing steps, including missing verification signatures, incomplete activity records, and out-of-order line stoppage logs. These issues indicate a failure to maintain adequate control over critical production data.