# FDA 483 - Viant San Antonio, Inc. - March 19, 2026

Source: https://www.keypedia.com/records/483/viant-san-antonio-inc/8a5b0bf9-8506-4ccc-8cba-941e99213295

> FDA 483 for Viant San Antonio, Inc. on March 19, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viant San Antonio, Inc.
- Inspection Date: 2026-03-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Viant San Antonio, Inc., a manufacturer of Class II medical device tubing, revealed significant deficiencies in product realization planning. The firm failed to adequately define required activities and controls within its pFMEA, leading to unmitigated risks for potential patient harm. This was further evidenced by multiple complaints regarding leaking and hair in the tubing, which were not adequately addressed in the risk management process.

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Richard F Riggle](https://www.keypedia.com/people/richard-f-riggle/5e0c278a-2e80-47ca-aa1a-80fb88c7f7a1)

Company: https://www.keypedia.com/companies/viant-san-antonio-inc/8cec2d16-4973-47d2-a4a6-b25a40a3537d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab