# FDA 483 - Gottfried Medical, Inc. - July 31, 2025

Source: https://www.keypedia.com/records/483/gottfried-medical-inc/f0090e05-417b-424c-a809-a09aa67613b1

> FDA 483 for Gottfried Medical, Inc. on July 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gottfried Medical, Inc.
- Inspection Date: 2025-07-31
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Gottfried Medical, Inc. in Toledo, OH, a medical device manufacturer, was cited with three observations on a Form FDA 483. The inspection revealed deficiencies in controlling non-conforming products, inadequate procedures for supplier and raw material controls, and a failure to include Unique Device Identifiers (UDI) on medical device labels. These issues indicate significant concerns with the firm's quality system and compliance with device labeling regulations.

## Related Documents

- [WARNING_LETTER - 2015-03-24](https://www.keypedia.com/records/warning_letter/gottfried-medical-inc/9fb909e5-f6e7-49d5-85d1-566d41add11d)
- [483 - 2025-07-31](https://www.keypedia.com/records/483/gottfried-medical-inc/48890b56-b608-4d35-86c8-f1bb7afc3233)

## Related Officers

- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/gottfried-medical-inc/523f87b4-4f08-4b8d-822b-93f0c83a049a

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