FDA 483 - Helget Gas Products Inc - May 25, 2023

Helget Gas Products Inc. in Bridgeton, MO, a medical gas manufacturer, was inspected and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, labeling procedures, complaint handling, product testing, employee training, annual reviews, and facility maintenance. Key issues include illegible lot codes, lack of SOPs for label control, and failure to conduct required product testing.