FDA 483 - Kwang Yang Motor Co., Ltd. - August 16, 2018

An FDA inspection of Kwang Yang Motor Co., Ltd. in Kaohsiung, Taiwan, revealed significant deficiencies in their quality system documentation. Observations included inadequate documentation of corrective and preventive action (CAPA) activities, results of design risk analysis, and design verification results in the design history file. These issues indicate a need for improved record-keeping and quality control processes.