FDA 483 - Nox Bellcow Cosmetics Co., Ltd.

Nox Bellcow Cosmetics Co. Ltd. in Zhongshan City, China, an Over the Counter Drug Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight systemic failures in quality unit responsibilities, production and process controls, data integrity, and laboratory operations. These issues indicate a broad lack of adherence to current Good Manufacturing Practice requirements for OTC drug products.