# FDA 483 - TriReme Medical, LLC. - October 30, 2019

Source: https://www.globalkeysolutions.net/records/483/trireme-medical-llc/ec9a32c2-7396-4684-a6d3-ef6734809bff

> FDA 483 for TriReme Medical, LLC. on October 30, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TriReme Medical, LLC.
- Inspection Date: 2019-10-30
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: ReReme Medical, LLC, a sponsor in Pleasanton, CA, was cited for deficiencies during an FDA inspection related to an investigational study. The firm failed to ensure proper monitoring, specifically lacking documentation for follow-up on adverse event queries. Additionally, the inspection revealed issues with investigator agreements, including incomplete financial disclosure commitments, inaccurate financial disclosures, and agreements not being obtained prior to investigator participation.

## Related Documents

- [483 - 2022-06-17](https://www.globalkeysolutions.net/records/483/trireme-medical-llc/26246c60-6c23-4682-b463-8ac5ab59d1d4)

## Related Officers

- [Kristin M. Abaonza](https://www.globalkeysolutions.net/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.globalkeysolutions.net/companies/trireme-medical-llc/e86cba28-d4a5-4a05-acff-59074b157a0c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b