# FDA 483 - Oak Ridge Products - April 01, 2026

Source: https://www.keypedia.com/records/483/oak-ridge-products/c1ff3ccf-9d5c-43f6-9257-048c7571af85

> FDA 483 for Oak Ridge Products on April 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oak Ridge Products
- Inspection Date: 2026-04-01
- Product Type: device
- Office Name: Chicago District Office
- Summary: Oak Ridge Products, LLC, a manufacturer of Class II Slide Lid Sharp Containers in McHenry, IL, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in their quality management system, particularly concerning documentation for design changes, corrective actions, nonconforming products, complaint handling, management reviews, and internal audits. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements.

## Related Documents

- [483 - 2022-09-30](https://www.keypedia.com/records/483/oak-ridge-products/a1179c97-48ef-43f5-8953-e37fdc7ba35f)

## Related Officers

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

Company: https://www.keypedia.com/companies/oak-ridge-products/3beacb33-dcdb-4d02-9cd1-84e72e19ae97

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