FDA 483 - Hubei Honch Pharmaceutical Co, Ltd.

An FDA inspection of Hubei HONCH Pharmaceutical Co., Ltd. in Qichun County, China, revealed two significant observations. The firm's manufacturing building had unsuitable ceiling construction, failing to provide a GMP-compliant smooth surface for proper cleaning and maintenance. Additionally, the inspection found inadequate electronic data backup procedures and insufficient password controls for computer systems, raising concerns about data integrity and loss prevention.