FDA 483 - Health Body World Supply Inc. dba The Wabbo Company - May 24, 2022

An FDA inspection of Health Body World Supply Inc. dba The Wahs Company in Lake Elsinore, CA, a specification developer for Class II acupuncture needles, revealed a significant deficiency. The firm has not established required design control procedures for its medical devices. This indicates a fundamental lack of a quality system element crucial for ensuring device safety and effectiveness.