# FDA 483 - Trilliant Surgical, LLC - December 11, 2019

Source: https://www.globalkeysolutions.net/records/483/trilliant-surgical-llc/35f5a8c5-3043-4457-872f-6020ccdc0ce5

> FDA 483 for Trilliant Surgical, LLC on December 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trilliant Surgical, LLC
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Dallas District Office
- Summary: Trilliant Surgical, LLC in Houston, TX, received a Form FDA 483 with five observations highlighting significant deficiencies in its quality management system. The inspection revealed inadequate procedures for design transfer, supplier control, complaint handling, and process validation documentation. Additionally, the firm failed to properly complete medical device manufacturer reports by omitting required evaluation codes.

## Related Officers

- [Realtor](https://www.globalkeysolutions.net/people/phillip-m-pontikos/8533de8d-9be2-4bc9-9180-e3cd8d7f3386)
- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/trilliant-surgical-llc/c8b704a1-f4d4-4207-89e0-d11c7164d6a8

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9