# Bionix, Llc – FDA 483, Jul 14, 2026

Source: https://www.keypedia.com/records/483/bionix-llc/80991e9f-b0c0-49b9-83ba-ff02749c30e4

> FDA 483 for Bionix, Llc on July 14, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bionix, Llc
- Inspection Date: 2026-07-14
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Bionix, Llc in Maumee, OH, a medical device manufacturer, revealed significant deficiencies across its quality management system. The firm failed to adequately perform design and development verification, establish purchasing controls, and properly evaluate and control critical suppliers. Additionally, issues were noted in maintaining risk management records, applying a risk-based approach to quality, documenting quality system procedures, and ensuring complete complaint investigation records, including MDR reportability and UDI capture.

## Related Officers

- [investigator](https://www.keypedia.com/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.keypedia.com/companies/bionix-llc/19876df5-bcee-496c-985f-38115caf87ed

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22