# FDA 483 - Faretec Inc - July 13, 2022

Source: https://www.globalkeysolutions.net/records/483/faretec-inc/ca8ea848-1644-4a1e-8bd9-1c8c3b064d25

> FDA 483 for Faretec Inc on July 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Faretec Inc
- Inspection Date: 2022-07-13
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Faretec Inc. in Painesville, OH, revealed inadequate procedures for handling product complaints. The firm failed to consistently evaluate product returns, including those due to unsatisfied customers, as formal complaints, leading to inconsistent documentation. This indicates a deficiency in their complaint management system.

## Related Officers

- [Brian M Marosan](https://www.globalkeysolutions.net/people/brian-m-marosan/7954e296-d16b-4a87-b773-038732777bb8)

Company: https://www.globalkeysolutions.net/companies/faretec-inc/b1fdd7d7-595e-4cd8-83cf-091a796e2767

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