FDA 483 - Wuhan Humanwell Likang Pharmaceutical Co.,Ltd. - March 20, 2025

Hubei Honch Pharmaceutical Co, Ltd. in Huanggang, China, was inspected by the FDA from March 17-20, 2025. The inspection revealed two significant issues related to laboratory controls, specifically deficiencies in documenting testing method suitability and inadequate controls over computer systems to ensure authorized changes to control records. These observations indicate a lack of robust quality control in their analytical processes.