FDA 483 - Helget Gas Products, Inc. - August 05, 2025

Helget Gas Products, Inc. in Bensenville, IL, a medical gas manufacturer, was inspected from August 4-5, 2025. The inspection revealed significant issues with the firm's record-keeping and investigation processes for unexplained discrepancies and deviations. Specifically, the firm failed to document and investigate delays in annual records review and thermometer calibration, indicating a lack of robust quality control.