# FDA 483 - Uramix Inc - May 20, 2025

Source: https://www.keypedia.com/records/483/uramix-inc/170bf019-7b3b-4fc4-826f-dc0ea5d9206f

> FDA 483 for Uramix Inc on May 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Uramix Inc
- Inspection Date: 2025-05-20
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Uramix Inc, a manufacturer of class 2 sterile medical devices in Lansdowne, PA, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for critical areas such as management controls, design controls, corrective and preventative actions, and customer complaint management. Additionally, the firm failed to develop and implement written procedures for Medical Device Reporting (MDR).

## Related Officers

- [Investigations](https://www.keypedia.com/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.keypedia.com/companies/uramix-inc/55166b8b-c674-44f1-91f2-8c3aadf9857d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8