# FDA 483 - Rockwell Medical, Inc - November 20, 2025

Source: https://www.keypedia.com/records/483/rockwell-medical-inc/e06731f9-dbb2-4d75-aaee-23ed6eceda2a

> FDA 483 for Rockwell Medical, Inc on November 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockwell Medical, Inc
- Inspection Date: 2025-11-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Rockwell Medical, Inc. in Wixom, MI, was inspected and received a Form FDA 483 with three observations. The inspection revealed deficiencies in documenting non-reporting decisions for product corrections/removals, inadequate corrective and preventive action procedures, and insufficient response to out-of-tolerance test equipment. These issues indicate a lack of robust quality system controls for device manufacturing and complaint handling.

## Related Documents

- [EIR - 2015-04-03](https://www.keypedia.com/records/eir/rockwell-medical-inc/c2d77ba0-aeeb-4cb3-96fa-ac220f7c0353)
- [483 - 2015-04-03](https://www.keypedia.com/records/483/rockwell-medical-inc/0f8bc99e-2bb5-480e-93dc-6c18df7ae9f5)
- [483 - 2025-11-20](https://www.keypedia.com/records/483/rockwell-medical-inc/fb395f2f-cb53-44c9-80e7-4cd9acc8bb61)

## Related Officers

- [investigator](https://www.keypedia.com/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.keypedia.com/companies/rockwell-medical-inc/773d8d8c-13b2-4c27-9389-dd8993ea6d0c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0