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483
•Airgas USA, LLC•March 12, 2021

FDA 483 - Airgas USA, LLC - March 12, 2021

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Record Details

An FDA inspection of Airgas USA, LLC in Ventura, CA, a medical gas establishment, identified one observation related to the failure to follow written production and process control procedures. Specifically, an employee failed to complete label reconciliation documentation for Oxygen, USP cylinders, and the batch was subsequently released by Quality Control with incomplete records. This indicates a lapse in adherence to established manufacturing protocols.

Company
Airgas USA, LLC
Inspection Date
March 12, 2021
Product Type
Drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Kouros Kangarli
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ID · 748fb098-2ee9-4134-8fbc-aafd8717de93

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