FDA 483 - Kingkey MBC Life Technology Group Co., Ltd. - March 04, 2019

An FDA inspection of Kingkey MBC Life Technology Group Co., Ltd. in Chenghai, Shantou, Guangdong, China, revealed significant deficiencies in their manufacturing processes. Observations included inadequate laboratory controls for sampling plans, a lack of proper two-person verification for component additions and weight checks, and the absence of routine calibration for critical electronic equipment. These findings indicate a failure to adhere to established quality control and good manufacturing practices.