FDA 483 - A-Ox Welding Supply Co., Inc. - July 17, 2023

An FDA inspection of A-Ox Welding Supply Co., Inc. in Sioux Falls, SD, a medical gas manufacturer, revealed a significant issue regarding the control of labeling operations. The firm failed to consistently perform routine label reconciliation and documentation, and Quality Control Unit employees did not verify label issuance or removal from bulk inventory. This indicates a lack of strict control over critical labeling processes.