# FDA 483 - Rockwell Medical Inc. - March 16, 2023

Source: https://www.keypedia.com/records/483/rockwell-medical-inc/d7e4924a-a0fa-46e1-9d9b-6365791d7dba

> FDA 483 for Rockwell Medical Inc. on March 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockwell Medical Inc.
- Inspection Date: 2023-03-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Rockwell Medical Inc. in Washington, IA, revealed a significant issue regarding device history records and unique device identifiers. The firm failed to include or refer to UDI or UPC information in the device history record for its Class II 45X Acid Mixer, indicating a lack of proper UDI labeling implementation. This suggests a moderate severity finding related to medical device labeling and record-keeping compliance.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/rockwell-medical-inc/c0622fe3-01ce-4431-baba-9b87ae27d197

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8