# FDA 483 - Vesco Medical Llc - October 31, 2023

Source: https://www.globalkeysolutions.net/records/483/vesco-medical-llc/1b6e9bec-2383-4c34-b604-5cbfc46fe0f3

> FDA 483 for Vesco Medical Llc on October 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vesco Medical Llc
- Inspection Date: 2023-10-31
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Vesco Medical Llc, a specification developer in Westerville, OH, was cited for significant deficiencies in its quality management system during an FDA inspection. Observations included a failure to adequately establish corrective and preventive actions, a lack of design control procedures for medical devices, and insufficient investigation of customer complaints regarding device failures. Additionally, the firm failed to properly evaluate its Class I suppliers according to its own purchasing controls.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.globalkeysolutions.net/companies/vesco-medical-llc/2117099c-d458-4543-a42e-1dde62d36181

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