FDA 483 - August Bioservices LLC - April 18, 2025

August Bioservices, LLC, a sterile drug manufacturer in Nashville, TN, was cited for significant deficiencies in its quality systems. Observations included inadequate investigations into environmental monitoring excursions and particle defects, failures in good documentation practices and deviation management, and disorderly storage of materials. These issues indicate a lack of thoroughness in quality control and adherence to established procedures, potentially impacting product quality and patient safety.