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

Source: https://www.keypedia.com/records/483/essex-industries-inc/ea009394-1224-41e8-83f7-563684cddbed

> FDA 483 for Essex Industries, Inc. on December 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Essex Industries, Inc.
- Inspection Date: 2022-12-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

Company: https://www.keypedia.com/companies/essex-industries-inc/ea0b5450-4e1e-41b1-aaf5-57c27d5f2521

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8