FDA 483 - Mentholatum (China) Pharmaceuticals Co., Ltd. - June 21, 2019

Mentholatum (China) Pharmaceuticals Co., Ltd. in Zhongshan, China, a drug manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate laboratory controls, specifically concerning method verification for an assay, and a failure to thoroughly review unexplained discrepancies. These issues indicate deficiencies in quality control and assurance processes.