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华熙生物:通过美国FDA现场检查

Core Viewpoint - The company successfully passed the FDA's cGMP inspection with zero deficiencies, indicating high standards in its quality management system and manufacturing practices [1] Group 1: FDA Inspection Details - The FDA conducted a cGMP inspection from March 24 to March 28, 2025, covering six major systems: quality system, facilities and equipment, material system, production system, laboratory system, and packaging and labeling [1] - The inspection focused on the sodium hyaluronate active pharmaceutical ingredient [1] Group 2: Company Recognition - This marks the fifth time the company has passed an FDA inspection since its first participation in 2012, demonstrating consistent recognition from international regulatory authorities [1] - Achieving a "zero deficiency" status is the highest recognition from the FDA regarding compliance with drug production quality systems, signifying that the company's quality management system meets international high standards [1]