FDA 483 - Nikao, Inc. - February 18, 2022

Nikao, Inc. in Weston, FL, a contract manufacturer, received a Form FDA 483 with six observations during an inspection from February 15-18, 2022. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, corrective and preventive actions, process validation, design change control, labeling, and medical device reporting procedures. These issues indicate a lack of adequate implementation and establishment of critical quality system processes.