FDA 483 - Airgas USA, LLC - June 17, 2021

An FDA inspection of Airgas USA, LLC - Phoenix University Street, a medical gas facility, revealed significant deficiencies in its complaint handling system. The firm failed to include investigation findings in complaint records for compressed Oxygen, USP, and did not adhere to its own procedures for timely closure or documentation of extensions for complaint investigations. These issues indicate a lack of proper control over product quality and potential risks to public health.