# FDA 483 - Grafton Medical Alliance - October 26, 2023

Source: https://www.globalkeysolutions.net/records/483/grafton-medical-alliance/9947cd30-c05a-48bd-b8f1-a1db05afb952

> FDA 483 for Grafton Medical Alliance on October 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grafton Medical Alliance
- Inspection Date: 2023-10-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Grafton Medical Alliance in Burr Ridge, IL, a repackager/relabeler and specification developer of Class 2 medical devices, identified two significant quality system deficiencies. The firm failed to adequately maintain complaint files, a repeat observation, and did not establish adequate procedures for corrective and preventive actions, including failing to initiate CAPAs for prior FDA audit nonconformances.

## Related Documents

- [483 - 2021-08-04](https://www.globalkeysolutions.net/records/483/grafton-medical-alliance/129fe8a4-aaa4-4275-9bd5-0f327136389a)

## Related Officers

- [Natasha R. Johnson](https://www.globalkeysolutions.net/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

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