FDA 483 - CAO Medical Equipment Co., Ltd. - July 20, 2018

An FDA inspection of Cao Medical Equipment Co., Ltd. in Langfang, China, from July 16-20, 2018, revealed 25 significant deficiencies in their manufacturing processes for drug products shipped to the U.S. The observations highlighted critical failures in process validation, quality unit oversight, facility maintenance, equipment calibration, and laboratory controls. Several issues were repeat observations, indicating a systemic lack of adherence to Good Manufacturing Practices.