Trilliant Surgical, LLCDecember 11, 2019

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

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Record Details

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.

Company: Trilliant Surgical, LLC
Inspection Date: December 11, 2019
Product Type: Device
Office: Dallas District Office
People: Phillip M. Pontikos (Realtor)
Ellen J. Tave

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ID · 35f5a8c5-3043-4457-872f-6020ccdc0ce5