FDA 483 - Livzon Group (Ningxia) Pharmaceutical Co., Ltd. - December 06, 2019

Lizvon Group (Ningxia) Pharmaceutical Co., an intermediate and API manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures in maintaining manufacturing equipment, specifically rusted tanks, and a lack of thorough investigation into out-of-specification results for multiple batches. These findings indicate issues with equipment integrity and quality control processes.