FDA 483 - Roquette America, Inc. - January 30, 2026

Roquette America, Inc. in Keokuk, IA, an API manufacturer, was cited for three observations during an FDA inspection. The firm failed to adequately control its stability testing program, including late timepoints and premature destruction of samples. Additionally, the company did not adequately investigate the root cause of batch failures due to extraneous material and lacked proper oversight of cleaning validation for packing equipment. Finally, rejected materials were not properly quarantined or destroyed, posing a risk of unauthorized use.