Shandong Anxin Pharmaceutical Co., Ltd. – FDA 483, Aug 21, 2024

Shandong Anxin Pharmaceutical Co., Ltd. in Jinan City, China, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate procedures to prevent microbiological contamination, insufficient validation of aseptic processes, and flawed environmental monitoring. Additionally, the firm failed to thoroughly investigate out-of-specification results and lacked appropriate controls over computer systems for data integrity.