Bloomage Bio passes FDA inspection with zero deficiencies

Bloomage Biotechnology Corporation [SSE:688363] announced that it successfully passed a U.S. Food and Drug Administration (FDA) on-site inspection with zero deficiencies ("0-483"). The inspection, which took place from March 24 to March 28, 2025, covered key areas including quality systems, facilities, equipment, material handling, production, laboratories, and packaging related to the company's sodium hyaluronate active pharmaceutical ingredient (API) manufacturing. This marks the fifth successful FDA inspection for Bloomage Bio since its first participation in 2012. The company highlights that achieving zero deficiencies represents the highest level of FDA recognition for compliance, demonstrating the company's commitment to international quality standards. Bloomage Bio believes this result enhances its global partnerships and creates favorable conditions for expanding its international market presence.