# FDA 483 - OMT, LLC - September 02, 2022

Source: https://www.keypedia.com/records/483/omt-llc/11a94863-36ec-4e71-bd0b-b5d2c6187a58

> FDA 483 for OMT, LLC on September 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OMT, LLC
- Inspection Date: 2022-09-02
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of GMT, LLC, a medical device specification developer in Fort Lauderdale, FL, revealed three significant repeat deficiencies. The firm failed to adequately establish procedures for design validation, specifically regarding aging studies for OMT Spetzler Neuro Patties, and had not properly implemented its quality audit procedure. Additionally, the inspection found that procedures for ensuring purchased products and services conform to requirements were not adequately established, leading to issues with supplier complaint handling.

## Related Documents

- [483 - 2025-03-05](https://www.keypedia.com/records/483/omt-llc/e7c35333-43fa-47a2-ab42-d468fb178f15)

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/omt-llc/a7a79040-cf31-4edd-9c79-29d85a0e42dd

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