FDA 483 - AIRGAS USA, LLC. - November 04, 2021

The FDA conducted an inspection of Airgas USA, LLC, a medical gas manufacturer located in Oklahoma City, OK, from November 1 to November 4, 2021. The inspection revealed several critical compliance issues primarily related to the firm's quality and laboratory systems.

Key observations included a failure to investigate discrepancies in oxygen analyzer calibration, as outlined in the firm's procedure OKCAW-302. Specifically, discrepancies in maintenance tolerance values were recorded but not investigated, contrary to procedural requirements. Additionally, the inspection highlighted inadequate employee training. The Plant Manager was unaware of the requirements for testing and trending results of bulk drug products, including Liquid Oxygen USP and Liquid Nitrogen NF, as per Procedure DP 5.4.2. Furthermore, there was no documentation of training provided for this procedure, which is supposed to be part of the AMG Quality Management System training.

The laboratory system also faced scrutiny for not following established sampling plans and test procedures. The required testing and trending by Quality Assurance were not performed, indicating a significant gap in compliance with internal protocols.

These observations were reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates that any insanitary conditions observed during inspections be documented and addressed. Airgas USA, LLC is required to investigate these discrepancies, ensure adequate training for employees, and adhere to established testing protocols to comply with FDA regulations.