FDA 483 - Anqiu Lu'an Pharmaceutical Co., Ltd. - September 22, 2025

An FDA inspection of Anqiu Lu'an Pharmaceutical Co., Ltd., an API manufacturer in Weifang, China, revealed two significant observations. The firm's periodic electronic raw data review was found to be inadequate, lacking scientific rationale for sample size and assessment frequency. Additionally, the sampling methods for cleaning monitoring of equipment were deemed not scientifically sound, with critical areas not assessed during validation.