Roquette America, Inc. – FDA EIR, Jun 17, 2021

An FDA surveillance inspection of Roquette America, Inc.'s Keokuk, IA facility was conducted from June 14-17, 2021. The inspection focused on the company's active pharmaceutical ingredient (API) and excipient manufacturing operations for products like dextrose monohydrate and sorbitol, under the regulatory framework of current Good Manufacturing Practices (cGMP) for API processes. This inspection identified two significant observations documented on Form FDA 483. Firstly, the company failed to perform required resolution or system suitability testing for HPLC assay, including impurity assays, on Dextrose Monohydrate API from November 2018 to November 2019. Secondly, there was inadequate control over the number of copies production employees could print for in-process laboratory results, compromising document control. Additionally, several deficiencies were verbally discussed with management. These included rusted LAL testing equipment, peeling paint near a sampling port, lack of pre-packaging line double-checks for label printing accuracy, the Quality Unit's failure to establish and monitor production yields, and issues with the FTIR system allowing data deletion and clock changes. An outdated process log sheet was also noted. Roquette America, Inc. management committed to addressing these observations and deficiencies, promising a written response to the FDA 483 within 15 working days. They were reminded of their ongoing responsibility to comply with the FD&C Act to prevent potential regulatory actions.