Airgas USA LLC – FDA 483, Apr 23, 2026

Airgas USA, LLC, a medical gas manufacturer in Kent, WA, was cited for significant quality control deficiencies during an FDA inspection. Observations included a lack of written procedures for managing non-operational equipment, critical documentation errors by a bulk driver, and inadequate investigations into internal non-conformances. Additionally, the firm failed to maintain proper calibration and accountability for its Distributed Control System due to the use of shared login credentials.