FDA 483 - Henan Lihua Pharmaceutical Co., Ltd. - December 11, 2017

An FDA inspection of Henan Lihua Pharmaceutical Co., Ltd., an API manufacturer in Anyang, China, revealed significant issues with record control and data integrity. Inspectors found uncontrolled blank manufacturing records and QA stamps, indicating a lack of proper documentation management. Additionally, the firm failed to maintain complete QC records due to software configurations that allowed data overwriting and the use of duplicate file names for analytical runs.