FDA 483 - Evive Biopharmaceutical (Beijing), Ltd. - June 07, 2023

Evive Biotechnology (Beijing) Ltd, a drug substance manufacturer, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies across multiple areas, including inadequate microbial contamination controls, environmental monitoring, cleanroom practices, deviation management, utility maintenance, temperature-controlled unit management, and good documentation practices. These issues indicate a systemic lack of control over critical manufacturing processes and quality systems.