FDA 483 - Amphastar Laboratories, Inc. - October 21, 2016

An FDA inspection of Alphastar Laboratories Inc. in Chino, CA, a non-clinical laboratory, revealed significant deficiencies in their Good Laboratory Practice (GLP) systems. Observations included failures in quality assurance oversight, inadequate archiving procedures, and multiple instances where study directors did not ensure protocol adherence, accurate data recording, or proper documentation of study changes. These issues indicate a systemic lack of control over critical aspects of non-clinical studies.