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

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.