# FDA 483 - Oxygen Therapy Institute - November 17, 2023

Source: https://www.keypedia.com/records/483/oxygen-therapy-institute/4e2d2ca0-e47e-4872-abb6-0a5245f1a40e

> FDA 483 for Oxygen Therapy Institute on November 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxygen Therapy Institute
- Inspection Date: 2023-11-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Oxygen Therapy Institute, a medical device manufacturer in Jacksonville, FL, was cited with twelve observations during an FDA inspection from November 13-17, 2023. The findings indicate significant deficiencies across multiple quality system areas, including a lack of established procedures for acceptance activities, supplier qualification, process controls, quality audits, complaint handling, nonconforming product, CAPA, MDRs, device history records, training, management review, and document approval. Many of these issues are repeat observations from a previous inspection over seven years ago, highlighting a systemic failure to implement and maintain a compliant quality system.

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/oxygen-therapy-institute/46c7ac60-3aea-4258-be56-b6f97318b562

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6