# FDA 483 - Xyresic Llc - December 16, 2024

Source: https://www.globalkeysolutions.net/records/483/xyresic-llc/3601d34b-c192-435e-aed4-54de1848590f

> FDA 483 for Xyresic Llc on December 16, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xyresic Llc
- Inspection Date: 2024-12-16
- Product Type: other
- Office Name: Detroit District Office
- Summary: Xyresic Llc, a contract manufacturer in Jackson, MI, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for controlling suppliers, including initial evaluation, classification, monitoring, and removal of approved suppliers. Additionally, procedures for controlling nonconforming products were deficient, specifically lacking documentation regarding the need for investigations on Non-Conformance Report forms.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/xyresic-llc/5a457302-7f98-4dbe-97de-dd7431779cc8

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03