Essex Industries, Inc.December 16, 2022

FDA 483 - Essex Industries, Inc. - December 16, 2022

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Record Details

Essex Industries, Inc. in Affton, MO, a medical device manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to submit a Medical Device Report (MDR) within the required timeframe after becoming aware of a Therapeutic Liquid Oxygen System malfunction. Additionally, the company did not adequately review and evaluate customer complaints and returned Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) devices.

Company: Essex Industries, Inc.
Inspection Date: December 16, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - West II
Person: Mary L. Schuckmann (issuing_officer)

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ID · ea009394-1224-41e8-83f7-563684cddbed