FDA 483 - Yibin Lihao Bio-technical Co., Ltd. - August 06, 2019

Yibin Lihao Bio-technical Co., Ltd. in Yibin, China, an Intermediate API Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues with data integrity, including non-contemporaneous and missing batch records, and a lack of control over documentation. Furthermore, the firm demonstrated inadequate quality unit oversight, poor facility and equipment maintenance, and insufficient employee training, indicating a systemic breakdown in their manufacturing processes.