FDA 483 - Astral SteriTech Private Ltd. - June 20, 2023

An FDA inspection of Astral SteriTech Private Ltd. in Vadodara, India, a sterile drug manufacturer, revealed four significant observations. The firm exhibited inadequate aseptic processing controls, including deficient cleaning and disinfection, and unreliable environmental monitoring data that led to a product recall. Further issues included poor facility maintenance in classified areas and a lack of validation for aseptic processes and sterilization, indicating severe breakdowns in quality control and manufacturing practices.