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

Source: https://www.keypedia.com/records/483/gottfried-medical-inc/48890b56-b608-4d35-86c8-f1bb7afc3233

> FDA 483 for Gottfried Medical, Inc. on July 31, 2025. Product: devices. 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: devices
- Summary: During an FDA inspection conducted from July 28 to July 31, 2025, Gottfried Medical, Inc., a medical device manufacturer in Toledo, OH, received a Form FDA 483 detailing three significant observations regarding its quality system. The main issues identified focused on deficiencies in controlling product quality and ensuring compliance with regulatory labeling requirements. Specifically, the firm's procedures for managing non-conforming products were found to be inadequate, with rework activities on compression garments not consistently documented. Furthermore, the company lacked sufficient controls over purchased products and services; for instance, a thread supplier was not listed on the approved supplier list, and there were no documented evaluations for key raw material suppliers, including thread and zipper providers. Finally, the inspection revealed that the labels for Gottfried Medical's finished medical support compression stocking devices did not include a Unique Device Identifier (UDI), which is a regulatory mandate under 21 CFR 801 Subpart B and 830. The firm acknowledged these observations and committed to implementing corrective actions to address each identified deficiency, aiming to ensure compliance with medical device 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/f0090e05-417b-424c-a809-a09aa67613b1)

## 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