# FDA 483 - Saris and Things, Inc. - June 10, 2026

Source: https://www.keypedia.com/records/483/saris-and-things-inc/1e49d6ca-de92-4e9b-b93e-34746991facf

> FDA 483 for Saris and Things, Inc. on June 10, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saris and Things, Inc.
- Inspection Date: 2026-06-10
- Product Type: device
- Office Name: Chicago District Office
- Summary: Saris and Things, Inc. in Plainfield, IL, a repackager/relabler of medical devices, received an FDA Form 483 for significant deficiencies in its quality management system. The firm failed to document and maintain critical aspects of its QMS, including risk management, software validation, supplier control, medical device files, and production control. These findings indicate a fundamental lack of adherence to applicable regulatory requirements for medical device operations.

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)

Company: https://www.keypedia.com/companies/saris-and-things-inc/5d7bd8d8-2088-418c-994d-3700006622f1

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669