FDA 483 - Roquette America, Inc. - June 14, 2021

An FDA inspection of Roquette America, Inc. in Keokuk, IA, revealed significant quality control deficiencies. The firm failed to perform resolution or system suitability for HPLC assay on Dextrose Monohydrate API finished product testing for an extended period. Additionally, there was a lack of control over the printing of in-process laboratory results by production employees.