Amphastar Laboratories, Inc. – FDA EIR, Oct 21, 2016

This FDA Good Laboratory Practice (GLP) inspection of Amphastar Laboratories, Inc. in Chino, CA, was conducted from October 17-21, 2016. The unannounced, initial inspection reviewed non-clinical laboratory operations related to studies for NDA 205920: Epinephrine Inhalation Aerosol USP. The inspection identified ten significant deficiencies under GLP regulations. Key issues included the Quality Assurance Unit's (QAU) failure to inspect studies at adequate intervals and maintain independence from study conduct. There were widespread problems with protocol management, such as undocumented changes to study design (e.g., animal housing, treatment sessions), lack of clear study objectives in protocols, and the study director not ensuring protocol adherence. Data integrity and archiving practices were also cited; raw data, including email correspondence, was not fully transferred to archives, and access to archive facilities was inadequately controlled. Additionally, the facility lacked current training and experience summaries for personnel, and final study reports omitted names of contributing scientists. Amphastar Laboratories' management committed to rectifying these deficiencies in future non-clinical laboratory studies and indicated they would provide a formal written response to the Agency within fifteen business days.