FDA 483 - ENDO USA, Inc. - August 09, 2018

Par Sterile Products, LLC in Rochester, MI, received a Form FDA 483 with 13 observations during an inspection from July 31 to August 9, 2018. The observations primarily highlight significant deficiencies in aseptic processing, environmental monitoring, contamination control, and quality system procedures, including inadequate investigations, training, and documentation. These issues indicate a lack of assurance in preventing microbiological contamination and ensuring product quality for sterile drug products.