483
Helget Gas Products, Inc.Helget Gas Products, Inc. – FDA 483, Aug 5, 2025
Record Details
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.
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ID · 70f6d66b-767d-435d-a858-f22eda19703f
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