# FDA 483 - Viant AS&O Holdings, LLC - October 23, 2020

Source: https://www.globalkeysolutions.net/records/483/viant-aso-holdings-llc/a69dda4b-7320-4ea7-aaf1-fafea9225824

> FDA 483 for Viant AS&O Holdings, LLC on October 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viant AS&O Holdings, LLC
- Inspection Date: 2020-10-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Viant AS&O Holdings, LLC, a medical device manufacturer in Orchard Park, NY, received two observations during an FDA inspection. The firm was cited for inadequate procedures to control nonconforming product, which was a repeat observation, and for failing to validate software used in the production of finished medical devices. These findings highlight deficiencies in the firm's quality system and manufacturing process controls.

## Related Documents

- [483 - 2023-10-27](https://www.globalkeysolutions.net/records/483/viant-aso-holdings-llc/42ca6b4b-c5ed-4ea5-a7a5-64a5fe088bda)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/viant-aso-holdings-llc/f0845fd2-e51c-4bd3-9de7-b7aa64334fd4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961