FDA 483 - Hangzhou ApexTide Biomedical Technology Co., Ltd. - November 01, 2024

An FDA inspection of Hangzhou ApexTide Biomedical Technology Co., Ltd. in Hangzhou, China, revealed significant deficiencies in the manufacturing and quality control of Active Pharmaceutical Ingredients (API). The firm failed to complete process validation, adequately qualify manufacturing areas and equipment, and ensure proper testing of starting materials and water used in production. These issues raise concerns about the quality, purity, and stability of API shipped to the US market.