# FDA 483 - Rockwell Medical, Inc - April 03, 2015

Source: https://www.keypedia.com/records/483/rockwell-medical-inc/0f8bc99e-2bb5-480e-93dc-6c18df7ae9f5

> FDA 483 for Rockwell Medical, Inc on April 03, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockwell Medical, Inc
- Inspection Date: 2015-04-03
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Rockwell Medical, Inc. in Wixom, MI, was inspected regarding its medical device manufacturing. The inspection revealed significant deficiencies across design control processes, including validation, verification, review, and transfer, as well as inadequate process validation documentation and vendor approval procedures. These issues indicate a systemic lack of established and documented quality system procedures.

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## Related Officers

- [Amy Graf](https://www.keypedia.com/people/amy-graf/0d21b7b0-0137-47a1-b014-70e7391bc845)
- [investigator](https://www.keypedia.com/people/deanna-lampley/e894410f-2d65-4131-bc9a-930bb0b0d574)

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