FDA 483 - Beijing Zhangguang 101 Science & Technology Co., Ltd.

Beijing Zhongsheng 101 Science & Technology Co., Ltd. was inspected and cited for significant deficiencies in its manufacturing processes. Observations included inadequate stability data for drug product expiration dates, insufficient cleaning and maintenance procedures for equipment, and a failure to properly qualify suppliers for active pharmaceutical ingredients. The firm also failed to investigate unexplained discrepancies, indicating a lack of robust quality control.