# FDA 483 - Grafton Medical Alliance - August 04, 2021

Source: https://www.globalkeysolutions.net/records/483/grafton-medical-alliance/129fe8a4-aaa4-4275-9bd5-0f327136389a

> FDA 483 for Grafton Medical Alliance on August 04, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grafton Medical Alliance
- Inspection Date: 2021-08-04
- Product Type: other
- Office Name: Chicago District Office
- Summary: Grafton Medical Alliance, a repacker/relabeler in Burr Ridge, IL, was cited with two observations during an FDA inspection. The firm failed to maintain complaint files, specifically regarding the proper documentation of "screwdriver stripped" complaints. Additionally, the quality policy was not properly established by management, lacking required signatures from the CEO and COO.

## Related Documents

- [483 - 2023-10-26](https://www.globalkeysolutions.net/records/483/grafton-medical-alliance/9947cd30-c05a-48bd-b8f1-a1db05afb952)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/grafton-medical-alliance/e356cd27-07e8-4a2e-8e9d-b47bfc60b354

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