FDA 483 - Shanghai Henlius Biologics Co., Ltd. - August 01, 2023

Shanghai Henlius Biologics Co., Ltd. was inspected from July 26 to August 4, 2023, and received a Form 483 with four observations. The inspection revealed deficiencies in fill line setup procedures, ambient storage area qualifications, facility microbial control, and documentation for a specific test method. These issues indicate a need for improved quality control and procedural adherence.