FDA 483 - Jiangsu Anbison Pharmaceutical Co., Ltd. - July 16, 2024

An FDA inspection of Jiangsu Anbison Pharmaceutical Co., Ltd. in Taizhou, China, revealed significant deficiencies in their manufacturing operations. Observations included inadequate quality control unit procedures for reviewing audit trails, insufficient validation of aseptic processes for sterile drug products, and deficiencies in environmental monitoring within aseptic processing areas. These issues indicate a lack of control over critical manufacturing processes and data integrity.